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Trial record 9 of 65 for:    dry mouth | NIH

Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

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ClinicalTrials.gov Identifier: NCT01316770
Recruitment Status : Terminated (Slow enrollment)
First Posted : March 16, 2011
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Sjögren's Syndrome
Xerostomia
Interventions Drug: Dexamethasone Parotid Irrigation
Drug: Placebo Parotid Irrigation
Enrollment 14
Recruitment Details 14 participants were screened in the United States. Nine of the participants were then eligible and enrolled between October, 2011 and Sep, 2013 and administered treatment.
Pre-assignment Details Screening occurred in two stages: Stage I (within 6 weeks before Stage II), and Stage II (within 6 weeks before randomization). Ten participants were eligible following the Stage I screening, but one subject loss their eligibility at Stage II screening because she refused the parotid biopsy.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28. Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Period Title: Overall Study
Number of participants Number of units (parotid glands) Number of participants Number of units (parotid glands)
Started 9 [1] 9 9 [2] 9
Completed 9 9 9 9
Not Completed 0 0 0 0
[1]
Each study participant received the dexamethasone parotid irrigation on one side of mouth.
[2]
Each study participant received the placebo parotid irrigation on the other side of mouth.
Arm/Group Title Overall Study
Hide Arm/Group Description Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
Overall Number of Baseline Participants 11
Overall Number of Units Analyzed
Type of Units Analyzed: Parotid glands
22
Hide Baseline Analysis Population Description
Safety Population: all enrolled participants that received any parotid saline irrigation used to determine parotid filling volume during Stage I screening.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Category Number Analyzed 11 participants
18-30 years
0
   0.0%
31-40 years
2
  18.2%
41-50 years
1
   9.1%
51-60 years
6
  54.5%
61-65 years
1
   9.1%
66-70 years
0
   0.0%
Missing
1
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
11
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
1
   9.1%
Not Hispanic or Latino
10
  90.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  27.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  18.2%
White
5
  45.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   9.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
 100.0%
Waist Circumference   [1] 
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 2 participants
98.0
(95 to 101)
[1]
Measure Analysis Population Description: On January 9, 2013, the field for waist circumference was removed as a required field in the database collection forms. As of that date, only 2 participants had records for waist circumference entered into the database.
Weight   [1] 
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 6 participants
68.95
(57.1 to 78.1)
[1]
Measure Analysis Population Description: On January 9, 2013, the field for weight was removed as a required field in the database collection forms. As of that date, only 6 participants had records for weight entered into the database.
Height   [1] 
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 6 participants
158.68
(132.0 to 170.5)
[1]
Measure Analysis Population Description: On January 9, 2013, the field for height was removed as a required field in the database collection forms. As of that date, only 6 participants had had records for height entered into the database.
Parotid Fill Volume   [1] [2] 
Median (Full Range)
Unit of measure:  mL/min
Parotid randomized to dexamethasone irrigation Number Analyzed 9 parotid glands [3] 
1.0
(0.6 to 1.0)
Parotid randomized to placebo irrigation Number Analyzed 9 parotid glands [3] 
1.0
(0.7 to 1.0)
Not randomized, right-side parotid Number Analyzed 2 parotid glands [4] 
0.875
(0.75 to 1.00)
Not randomized, left-side parotid Number Analyzed 2 parotid glands [4] 
0.875
(0.75 to 1.00)
[1]
Measure Description: Fill volumes were determined by injecting saline using a syringe into the parotid. Injection was terminated when the parotid volume was full or a maximum of 1 mL was injected.
[2]
Measure Analysis Population Description: Two participants in the Safety population were never randomized. These two participants were thus entered in the table as "not randomized"
[3]
9 participants
[4]
2 participants
Saliva Flow   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 9 parotid glands [2] 
Parotid randomized to dexamethasone irrigation 0.21250  (0.158850)
Parotid randomized to placebo irrigation 0.19096  (0.136399)
[1]
Measure Analysis Population Description: Two participants in the safety population were not randomized and thus their saliva flow was not recorded at their baseline randomization visit.
[2]
9 participants
Focus Score   [1] [2] 
Median (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 4 parotid glands [3] 
Parotid randomized to dexamethasone irrigation
2.5
(1 to 12)
Parotid randomized to placebo irrigation
1.5
(0 to 2)
[1]
Measure Description: Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).
[2]
Measure Analysis Population Description: The biopsy to determine the Focus score was only performed on the right-side parotid, thus only half the parotids have focus scores at baseline (4 dexamethasone randomized parotids; 4 placebo randomized parotids). Three parotids (participants) did not have biopsies at baseline (Stage I Screening).
[3]
4 participants
MRI Scan Evaluation   [1] [2] 
Count of Units
Unit of measure:  Parotid glands
Parotid randomized to dexamethasone irrigation Number Analyzed 9 parotid glands
Normal
5
  55.6%
Abnormal ncs
4
  44.4%
Abnormal cs
0
   0.0%
Not done
0
   0.0%
Parotid randomized to placebo irrigation Number Analyzed 9 parotid glands
Normal
5
  55.6%
Abnormal ncs
4
  44.4%
Abnormal cs
0
   0.0%
Not done
0
   0.0%
Not randomized, right-side parotid Number Analyzed 2 parotid glands
Normal
0
   0.0%
Abnormal ncs
0
   0.0%
Abnormal cs
0
   0.0%
Not done
2
 100.0%
Not randomized, left-side parotid Number Analyzed 2 parotid glands
Normal
0
   0.0%
Abnormal ncs
0
   0.0%
Abnormal cs
0
   0.0%
Not done
2
 100.0%
[1]
Measure Description: Baseline table counts are the count of parotid glands (2 per participant). In the table: "Abnormal, not clinically significant" is abbreviated as "Abnormal ncs"; "Abnormal, clinically significant" is abbreviated as "Abnormal cs".
[2]
Measure Analysis Population Description: Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Scan Evaluation   [1] [2] 
Count of Units
Unit of measure:  Parotid glands
Parotid randomized to dexamethasone irrigation Number Analyzed 9 parotid glands
Normal
4
  44.4%
Abnormal
5
  55.6%
Not done
0
   0.0%
Placebo randomized parotid: Normal Number Analyzed 9 parotid glands
Normal
4
  44.4%
Abnormal
5
  55.6%
Not done
0
   0.0%
Not randomized, right-side parotid Number Analyzed 2 parotid glands
Normal
0
   0.0%
Abnormal
1
  50.0%
Not done
1
  50.0%
Not randomized, left-side parotid Number Analyzed 2 parotid glands
Normal
0
   0.0%
Abnormal
1
  50.0%
Not done
1
  50.0%
[1]
Measure Description: Baseline table counts are the count of parotid glands (2 per participant)
[2]
Measure Analysis Population Description: Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Isotope Uptake   [1] [2] 
Count of Units
Unit of measure:  Parotid glands
Parotid randomized to dexamethasone irrigation Number Analyzed 9 parotid glands
Yes
9
 100.0%
No
0
   0.0%
Not done
0
   0.0%
Parotid randomized to placebo irrigation Number Analyzed 9 parotid glands
Yes
9
 100.0%
No
0
   0.0%
Not done
0
   0.0%
Not randomized, right-side parotid Number Analyzed 2 parotid glands
Yes
1
  50.0%
No
0
   0.0%
Not done
1
  50.0%
Not randomized, left-side parotid Number Analyzed 2 parotid glands
Yes
1
  50.0%
No
0
   0.0%
Not done
1
  50.0%
[1]
Measure Description: Baseline table counts are the count of parotid glands (2 per participant).
[2]
Measure Analysis Population Description: Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
Technetium Release with Stimulation   [1] [2] 
Count of Units
Unit of measure:  Parotid glands
Parotid randomized to dexamethasone irrigation Number Analyzed 9 parotid glands
Yes
8
  88.9%
No
1
  11.1%
Not done
0
   0.0%
Parotid randomized to placebo irrigation Number Analyzed 9 parotid glands
Yes
7
  77.8%
No
2
  22.2%
Not done
0
   0.0%
Not randomized, right-side parotid Number Analyzed 2 parotid glands
Yes
1
  50.0%
No
0
   0.0%
Not done
1
  50.0%
Not randomized, left-side parotid Number Analyzed 2 parotid glands
Yes
1
  50.0%
No
0
   0.0%
Not done
1
  50.0%
[1]
Measure Description: Baseline table counts are the count of parotid glands (2 per participant).
[2]
Measure Analysis Population Description: Two participants in the Safety population were never randomized. The left and right parotids for these 2 participants were thus entered in the table as "not randomized"
1.Primary Outcome
Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
Hide Description Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.
Time Frame Baseline (Study Day 0) to Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Population (PEP): all enrolled participants who receive all parotid irrigations on study Days 0 and 28, have the same treatment applied to the same parotid (regardless of random assignment) at both visits, and have values for the primary endpoint (i.e., change in salivary flow from Day 0 to Day 56).
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Mean (Standard Error)
Unit of Measure: g/min
-0.01120  (0.049063) -0.05204  (0.032029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
Comments The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction [that was specified in the statistical analysis plan (SAP) for the mixed model] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.
Type of Statistical Test Superiority
Comments The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.
Statistical Test of Hypothesis P-Value 0.236
Comments No corrections were made for multiple comparisons because there was only one primary hypothesis.
Method one-sided Paired t-test
Comments [Not Specified]
2.Secondary Outcome
Title Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.
Hide Description Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.
Time Frame Baseline to 14 days post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on Study Day 0 and Study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Overall Number of Units Analyzed
Type of Units Analyzed: Parotid gland from one side of the mouth
9 9
Mean (Standard Error)
Unit of Measure: g/min
-0.01106  (0.075004) 0.01875  (0.047825)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method one-sided paired t-test
Comments [Not Specified]
3.Secondary Outcome
Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.
Hide Description Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.
Time Frame Baseline to 28 days post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Overall Number of Units Analyzed
Type of Units Analyzed: Parotid gland on one side of the mouth
9 9
Mean (Standard Error)
Unit of Measure: g/min
-0.09808  (0.058960) -0.06678  (0.071649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method one-sided paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.
Hide Description Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.
Time Frame Baseline to 42 days post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Overall Number of Units Analyzed
Type of Units Analyzed: Parotid galnd on one side of the mouth
9 9
Mean (Standard Deviation)
Unit of Measure: g/min
0.00224  (0.055472) 0.01192  (0.031049)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone Irrigation of Parotid Gland, Placebo Irrigation of Parotid Gland
Comments The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method one-sided paired t-test
Comments [Not Specified]
5.Secondary Outcome
Title Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
3
  33.3%
No
6
  66.7%
Study Day 14 Yes
1
  11.1%
No
8
  88.9%
Study Day 28 Yes
2
  22.2%
No
7
  77.8%
Study Day 42 Yes
1
  11.1%
No
8
  88.9%
Study Day 56 Yes
2
  22.2%
No
7
  77.8%
6.Secondary Outcome
Title Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Number Analyzed 3 participants
Pain
0
   0.0%
Dryness
3
 100.0%
Weakness
0
   0.0%
Too few Teeth
0
   0.0%
Other
0
   0.0%
Study Day 14 Number Analyzed 1 participants
Pain
0
   0.0%
Dryness
1
 100.0%
Weakness
0
   0.0%
Too few Teeth
0
   0.0%
Other
0
   0.0%
Study Day 28 Number Analyzed 2 participants
Pain
0
   0.0%
Dryness
2
 100.0%
Weakness
0
   0.0%
Too few Teeth
0
   0.0%
Other
0
   0.0%
Study Day 42 Number Analyzed 1 participants
Pain
0
   0.0%
Dryness
1
 100.0%
Weakness
0
   0.0%
Too few Teeth
0
   0.0%
Other
0
   0.0%
Study Day 56 Number Analyzed 2 participants
Pain
0
   0.0%
Dryness
2
 100.0%
Weakness
0
   0.0%
Too few Teeth
0
   0.0%
Other
0
   0.0%
7.Secondary Outcome
Title Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
0
   0.0%
No
9
 100.0%
Study Day 14 Yes
0
   0.0%
No
9
 100.0%
Study Day 28 Yes
0
   0.0%
No
9
 100.0%
Study Day 42 Yes
0
   0.0%
No
9
 100.0%
Study Day 56 Yes
0
   0.0%
No
9
 100.0%
8.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
1
  11.1%
No
8
  88.9%
Study Day 14 Yes
2
  22.2%
No
7
  77.8%
Study Day 28 Yes
1
  11.1%
No
8
  88.9%
Study Day 42 Yes
0
   0.0%
No
9
 100.0%
Study Day 56 Yes
0
   0.0%
No
9
 100.0%
9.Secondary Outcome
Title Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Number Analyzed 1 participants
Foods taste different than they used to
0
   0.0%
Foods taste less intense (for example, less sweet)
0
   0.0%
Foods taste more intense (for example, more sweet)
1
 100.0%
I have persistent bad taste in my mouth
0
   0.0%
Study Day 14 Number Analyzed 2 participants
Foods taste different than they used to
0
   0.0%
Foods taste less intense (for example, less sweet)
1
  50.0%
Foods taste more intense (for example, more sweet)
1
  50.0%
I have persistent bad taste in my mouth
0
   0.0%
Study Day 28 Number Analyzed 1 participants
Foods taste different than they used to
1
 100.0%
Foods taste less intense (for example, less sweet)
0
   0.0%
Foods taste more intense (for example, more sweet)
0
   0.0%
I have persistent bad taste in my mouth
0
   0.0%
Study Day 42 Number Analyzed 0 participants
Foods taste different than they used to 0
Foods taste less intense (for example, less sweet) 0
Foods taste more intense (for example, more sweet) 0
I have persistent bad taste in my mouth 0
Study Day 56 Number Analyzed 0 participants
Foods taste different than they used to 0
Foods taste less intense (for example, less sweet) 0
Foods taste more intense (for example, more sweet) 0
I have persistent bad taste in my mouth 0
10.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
2
  22.2%
No
7
  77.8%
Study Day 14 Yes
2
  22.2%
No
7
  77.8%
Study Day 28 Yes
1
  11.1%
No
8
  88.9%
Study Day 42 Yes
1
  11.1%
No
8
  88.9%
Study Day 56 Yes
1
  11.1%
No
8
  88.9%
11.Secondary Outcome
Title Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify:
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Number Analyzed 2 participants
Mouth or tongue burns
1
  50.0%
I have tooth pain
0
   0.0%
I have gum pain
0
   0.0%
I have pain in my jaws or TMJ
1
  50.0%
Study Day 14 Number Analyzed 2 participants
Mouth or tongue burns
1
  50.0%
I have tooth pain
0
   0.0%
I have gum pain
0
   0.0%
I have pain in my jaws or TMJ
1
  50.0%
Study Day 28 Number Analyzed 1 participants
Mouth or tongue burns
0
   0.0%
I have tooth pain
0
   0.0%
I have gum pain
0
   0.0%
I have pain in my jaws or TMJ
1
 100.0%
Study Day 42 Number Analyzed 1 participants
Mouth or tongue burns
1
 100.0%
I have tooth pain
0
   0.0%
I have gum pain
0
   0.0%
I have pain in my jaws or TMJ
0
   0.0%
Study Day 56 Number Analyzed 1 participants
Mouth or tongue burns
0
   0.0%
I have tooth pain
0
   0.0%
I have gum pain
0
   0.0%
I have pain in my jaws or TMJ
1
 100.0%
12.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
8
  88.9%
No
1
  11.1%
Study Day 14 Yes
9
 100.0%
No
0
   0.0%
Study Day 28 Yes
9
 100.0%
No
0
   0.0%
Study Day 42 Yes
9
 100.0%
No
0
   0.0%
Study Day 56 Yes
8
  88.9%
No
1
  11.1%
13.Secondary Outcome
Title Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Sip water
8
  88.9%
Baseline: Sip liquids other than water
6
  66.7%
Baseline: use commercial products
4
  44.4%
Baseline: Chew sugared gum or mints
1
  11.1%
Baseline: Chew sugarless gum or mints
2
  22.2%
Study Day 14: Sip water
8
  88.9%
Study Day 14: Sip liquids other than water
6
  66.7%
Study Day 14: use commercial products
3
  33.3%
Study Day 14: Chew sugared gum or mints
1
  11.1%
Study Day 14: Chew sugarless gum or mints
4
  44.4%
Study Day 28: Sip water
8
  88.9%
Study Day 28: Sip liquids other than water
7
  77.8%
Study Day 28: use commercial products
4
  44.4%
Study Day 28: Chew sugared gum or mints
2
  22.2%
Study Day 28: Chew sugarless gum or mints
3
  33.3%
Study Day 42: Sip water
7
  77.8%
Study Day 42: Sip liquids other than water
5
  55.6%
Study Day 42: use commercial products
3
  33.3%
Study Day 42: Chew sugared gum or mints
2
  22.2%
Study Day 42: Chew sugarless gum or mints
3
  33.3%
Study Day 56: Sip water
8
  88.9%
Study Day 56: Sip liquids other than water
3
  33.3%
Study Day 56: use commercial products
3
  33.3%
Study Day 56: Chew sugared gum or mints
1
  11.1%
Study Day 56: Chew sugarless gum or mints
2
  22.2%
14.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
1
  11.1%
No
6
  66.7%
Not Sure
2
  22.2%
Study Day 14 Yes
1
  11.1%
No
7
  77.8%
Not Sure
1
  11.1%
Study Day 28 Yes
2
  22.2%
No
7
  77.8%
Not Sure
0
   0.0%
Study Day 42 Yes
1
  11.1%
No
8
  88.9%
Not Sure
0
   0.0%
Study Day 56 Yes
1
  11.1%
No
7
  77.8%
Not Sure
1
  11.1%
15.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
3
  33.3%
No
6
  66.7%
Not Sure
0
   0.0%
Study Day 14 Yes
5
  55.6%
No
3
  33.3%
Not Sure
1
  11.1%
Study Day 28 Yes
3
  33.3%
No
5
  55.6%
Not Sure
1
  11.1%
Study Day 42 Yes
2
  22.2%
No
5
  55.6%
Not Sure
2
  22.2%
Study Day 56 Yes
2
  22.2%
No
6
  66.7%
Not Sure
1
  11.1%
16.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Too little
4
  44.4%
Too much
0
   0.0%
Do not notice it
5
  55.6%
Study Day 14 Too little
6
  66.7%
Too much
0
   0.0%
Do not notice it
3
  33.3%
Study Day 28 Too little
5
  55.6%
Too much
0
   0.0%
Do not notice it
4
  44.4%
Study Day 42 Too little
5
  55.6%
Too much
0
   0.0%
Do not notice it
4
  44.4%
Study Day 56 Too little
4
  44.4%
Too much
0
   0.0%
Do not notice it
5
  55.6%
17.Secondary Outcome
Title Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?
Hide Description The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Yes
1
  11.1%
No
8
  88.9%
Study Day 14 Yes
1
  11.1%
No
8
  88.9%
Study Day 28 Yes
3
  33.3%
No
6
  66.7%
Study Day 42 Yes
3
  33.3%
No
6
  66.7%
Study Day 56 Yes
1
  11.1%
No
8
  88.9%
18.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
2
  22.2%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
6
  66.7%
Study Day 28 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
2
  22.2%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
5
  55.6%
Study Day 42 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
2
  22.2%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
6
  66.7%
Study Day 56 Screening II: Yes; Study Day: Yes
2
  22.2%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
6
  66.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
19.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
9
 100.0%
Study Day 28 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
9
 100.0%
Study Day 42 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
9
 100.0%
Study Day 56 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
9
 100.0%
20.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
7
  77.8%
Study Day 28 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
7
  77.8%
Study Day 42 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
8
  88.9%
Study Day 56 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
8
  88.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
21.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
6
  66.7%
Study Day 28 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
7
  77.8%
Study Day 42 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
7
  77.8%
Study Day 56 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
7
  77.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
22.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
8
  88.9%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
0
   0.0%
Study Day 28 Screening II: Yes; Study Day: Yes
8
  88.9%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
0
   0.0%
Study Day 42 Screening II: Yes; Study Day: Yes
8
  88.9%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
0
   0.0%
Study Day 56 Screening II: Yes; Study Day: Yes
8
  88.9%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
1
  11.1%
23.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Number Analyzed 6 participants
Screening II: Yes; Study Day: Yes
1
  16.7%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
5
  83.3%
Study Day 28 Number Analyzed 7 participants
Screening II: Yes; Study Day: Yes
1
  14.3%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
6
  85.7%
Study Day 42 Number Analyzed 7 participants
Screening II: Yes; Study Day: Yes
1
  14.3%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
6
  85.7%
Study Day 56 Number Analyzed 6 participants
Screening II: Yes; Study Day: Yes
1
  16.7%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
0
   0.0%
Screening II: No; Study Day: No
5
  83.3%
24.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Number Analyzed 8 participants
Screening II: Yes; Study Day: Yes
2
  25.0%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
3
  37.5%
Screening II: No; Study Day: No
3
  37.5%
Study Day 28 Number Analyzed 8 participants
Screening II: Yes; Study Day: Yes
1
  12.5%
Screening II: Yes; Study Day: No
1
  12.5%
Screening II: No; Study Day: Yes
2
  25.0%
Screening II: No; Study Day: No
4
  50.0%
Study Day 42 Number Analyzed 7 participants
Screening II: Yes; Study Day: Yes
1
  14.3%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
1
  14.3%
Screening II: No; Study Day: No
5
  71.4%
Study Day 56 Number Analyzed 8 participants
Screening II: Yes; Study Day: Yes
1
  12.5%
Screening II: Yes; Study Day: No
1
  12.5%
Screening II: No; Study Day: Yes
1
  12.5%
Screening II: No; Study Day: No
5
  62.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
25.Secondary Outcome
Title Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?
Hide Description Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
7
  77.8%
Study Day 28 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
3
  33.3%
Screening II: No; Study Day: No
5
  55.6%
Study Day 42 Screening II: Yes; Study Day: Yes
1
  11.1%
Screening II: Yes; Study Day: No
0
   0.0%
Screening II: No; Study Day: Yes
2
  22.2%
Screening II: No; Study Day: No
6
  66.7%
Study Day 56 Screening II: Yes; Study Day: Yes
0
   0.0%
Screening II: Yes; Study Day: No
1
  11.1%
Screening II: No; Study Day: Yes
1
  11.1%
Screening II: No; Study Day: No
7
  77.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 14 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 14.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 28 is not equal to the probability of subjects shifting their answer from "no" at Screening to "yes" at Study Day 28.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 42 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 42.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments

McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 are equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Alternative hypothesis is that probability of subjects shifting from "yes" at Screening to "no" at Study Day 56 is not equal to the probability of subjects shifting from "no" at Screening to "yes" at Study Day 56.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
26.Secondary Outcome
Title Sjögren’s Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)
Hide Description Ordinal Scale 0:least to 10:greatest level of disease activity
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: units on a scale
Baseline
5
(4 to 7)
Study Day 14
5
(4 to 7)
Study Day 28
5
(4 to 7)
Study Day 42
5
(5 to 7)
Study Day 56
5
(5 to 7)
27.Secondary Outcome
Title Sjögren’s Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)
Hide Description Nominal scale values: Inactive; Low; Moderate; High
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Inactive
0
   0.0%
Low
2
  22.2%
Moderate
7
  77.8%
High
0
   0.0%
Study Day 14 Inactive
0
   0.0%
Low
2
  22.2%
Moderate
7
  77.8%
High
0
   0.0%
Study Day 28 Inactive
0
   0.0%
Low
2
  22.2%
Moderate
7
  77.8%
High
0
   0.0%
Study Day 42 Inactive
0
   0.0%
Low
3
  33.3%
Moderate
6
  66.7%
High
0
   0.0%
Study Day 56 Inactive
0
   0.0%
Low
4
  44.4%
Moderate
5
  55.6%
High
0
   0.0%
28.Secondary Outcome
Title Sjögren’s Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?
Hide Description Response: Yes or No
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Yes
0
   0.0%
No
9
 100.0%
Study Day 14 Yes
0
   0.0%
No
9
 100.0%
Study Day 28 Yes
0
   0.0%
No
9
 100.0%
Study Day 42 Yes
0
   0.0%
No
9
 100.0%
Study Day 56 Yes
0
   0.0%
No
9
 100.0%
29.Secondary Outcome
Title Sjögren’s Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: score on a scale
Baseline
5
(5 to 7)
Study Day 14
5
(5 to 7)
Study Day 28
5
(5 to 7)
Study Day 42
5
(5 to 7)
Study Day 56
5
(4 to 7)
30.Secondary Outcome
Title Sjögren’s Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren’s Syndrome (pSS) Activity is Now:
Hide Description Nominal Scale: Much better; Better; The same; Worse; Much worse
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered "not sure" were excluded from the shift tables.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Much better
0
   0.0%
Better
0
   0.0%
The same
7
  77.8%
Worse
2
  22.2%
Much worse
0
   0.0%
Study Day 14 Much better
0
   0.0%
Better
0
   0.0%
The same
7
  77.8%
Worse
2
  22.2%
Much worse
0
   0.0%
Study Day 28 Much better
0
   0.0%
Better
0
   0.0%
The same
7
  77.8%
Worse
2
  22.2%
Much worse
0
   0.0%
Study Day 42 Much better
0
   0.0%
Better
0
   0.0%
The same
9
 100.0%
Worse
0
   0.0%
Much worse
0
   0.0%
Study Day 56 Much better
0
   0.0%
Better
1
  11.1%
The same
8
  88.9%
Worse
0
   0.0%
Much worse
0
   0.0%
31.Secondary Outcome
Title Sjögren’s Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren’s Syndrome):
Hide Description Response: Yes; No
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Yes
1
  11.1%
No
8
  88.9%
Study 14 Yes
2
  22.2%
No
7
  77.8%
Study Day 28 Yes
2
  22.2%
No
7
  77.8%
Study Day 42 Yes
0
   0.0%
No
9
 100.0%
Study Day 56 Yes
0
   0.0%
No
9
 100.0%
32.Secondary Outcome
Title Sjögren’s Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days.
Hide Description Possible Response: Yes or No
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Yes
0
   0.0%
No
9
 100.0%
Study Day 28 Yes
0
   0.0%
No
9
 100.0%
Study Day 42 Yes
0
   0.0%
No
9
 100.0%
Study Day 56 Yes
0
   0.0%
No
9
 100.0%
33.Secondary Outcome
Title Sjörgen’s Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) through Study Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=5; Study Day 14 SDAI=5
4
  44.4%
Baseline SDAI=5; Study Day 14 SDAI=6
1
  11.1%
Baseline SDAI=6; Study Day 14 SDAI=5
1
  11.1%
Baseline SDAI=6; Study Day 14 SDAI=6
1
  11.1%
Baseline SDAI=6; Study Day 14 SDAI=7
1
  11.1%
Baseline SDAI=7; Study Day 14 SDAI=7
1
  11.1%
34.Secondary Outcome
Title Sjörgen’s Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) through Study Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=5; Study Day 28 SDAI=5
4
  44.4%
Baseline SDAI=5; Study Day 28 SDAI=6
1
  11.1%
Baseline SDAI=6; Study Day 28 SDAI=5
2
  22.2%
Baseline SDAI=6; Study Day 28 SDAI=7
1
  11.1%
Baseline SDAI=7; Study Day 28 SDAI=7
1
  11.1%
35.Secondary Outcome
Title Sjörgen’s Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) through Study Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=5; Study Day 42 SDAI=5
4
  44.4%
Baseline SDAI=5; Study Day 42 SDAI=6
1
  11.1%
Baseline SDAI=6; Study Day 42 SDAI=5
1
  11.1%
Baseline SDAI=6; Study Day 42 SDAI=6
2
  22.2%
Baseline SDAI=7; Study Day 42 SDAI=7
1
  11.1%
36.Secondary Outcome
Title Sjörgen’s Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=5; Study Day 56 SDAI=4
1
  11.1%
Baseline SDAI=5; Study Day 56 SDAI=5
3
  33.3%
Baseline SDAI=5; Study Day 56 SDAI=6
1
  11.1%
Baseline SDAI=6; Study Day 56 SDAI=5
2
  22.2%
Baseline SDAI=6; Study Day 56 SDAI=6
1
  11.1%
Baseline SDAI=7; Study Day 56 SDAI=7
1
  11.1%
37.Secondary Outcome
Title Sjörgen’s Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale
Hide Description Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.
Time Frame Baseline (Study Day 0) to Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Study Day 14 Baseline Inactive to Study Day Inactive
0
   0.0%
Baseline Inactive to Study Day Low
0
   0.0%
Baseline Inactive to Study Day Moderate
0
   0.0%
Baseline Inactive to Study Day High
0
   0.0%
Baseline Low to Study Day Inactive
0
   0.0%
Baseline Low to Study Day Low
2
  22.2%
Baseline Low to Study Day Moderate
0
   0.0%
Baseline Low to Study Day High
0
   0.0%
Baseline Moderate to Study Day Inactive
0
   0.0%
Baseline Moderate to Study Day Low
0
   0.0%
Baseline Moderate to Study Day Moderate
7
  77.8%
Baseline Moderate to Study Day High
0
   0.0%
Baseline High to Study Day Inactive
0
   0.0%
Baseline High to Study Day Low
0
   0.0%
Baseline High to Study Day Moderate
0
   0.0%
Baseline High to Study Day High
0
   0.0%
Study Day 28 Baseline Inactive to Study Day Inactive
0
   0.0%
Baseline Inactive to Study Day Low
0
   0.0%
Baseline Inactive to Study Day Moderate
0
   0.0%
Baseline Inactive to Study Day High
0
   0.0%
Baseline Low to Study Day Inactive
0
   0.0%
Baseline Low to Study Day Low
2
  22.2%
Baseline Low to Study Day Moderate
0
   0.0%
Baseline Low to Study Day High
0
   0.0%
Baseline Moderate to Study Day Inactive
0
   0.0%
Baseline Moderate to Study Day Low
0
   0.0%
Baseline Moderate to Study Day Moderate
7
  77.8%
Baseline Moderate to Study Day High
0
   0.0%
Baseline High to Study Day Inactive
0
   0.0%
Baseline High to Study Day Low
0
   0.0%
Baseline High to Study Day Moderate
0
   0.0%
Baseline High to Study Day High
0
   0.0%
Study Day 42 Baseline Inactive to Study Day Inactive
0
   0.0%
Baseline Inactive to Study Day Low
0
   0.0%
Baseline Inactive to Study Day Moderate
0
   0.0%
Baseline Inactive to Study Day High
0
   0.0%
Baseline Low to Study Day Inactive
0
   0.0%
Baseline Low to Study Day Low
2
  22.2%
Baseline Low to Study Day Moderate
0
   0.0%
Baseline Low to Study Day High
0
   0.0%
Baseline Moderate to Study Day Inactive
0
   0.0%
Baseline Moderate to Study Day Low
1
  11.1%
Baseline Moderate to Study Day Moderate
6
  66.7%
Baseline Moderate to Study Day High
0
   0.0%
Baseline High to Study Day Inactive
0
   0.0%
Baseline High to Study Day Low
0
   0.0%
Baseline High to Study Day Moderate
0
   0.0%
Baseline High to Study Day High
0
   0.0%
Study Day 56 Baseline Inactive to Study Day Inactive
0
   0.0%
Baseline Inactive to Study Day Low
0
   0.0%
Baseline Inactive to Study Day Moderate
0
   0.0%
Baseline Inactive to Study Day High
0
   0.0%
Baseline Low to Study Day Inactive
0
   0.0%
Baseline Low to Study Day Low
2
  22.2%
Baseline Low to Study Day Moderate
0
   0.0%
Baseline Low to Study Day High
0
   0.0%
Baseline Moderate to Study Day Inactive
0
   0.0%
Baseline Moderate to Study Day Low
2
  22.2%
Baseline Moderate to Study Day Moderate
5
  55.6%
Baseline Moderate to Study Day High
0
   0.0%
Baseline High to Study Day Inactive
0
   0.0%
Baseline High to Study Day Low
0
   0.0%
Baseline High to Study Day Moderate
0
   0.0%
Baseline High to Study Day High
0
   0.0%
38.Secondary Outcome
Title Sjörgen’s Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) to Study Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=4; Study Day 14 SDAI=4
1
  11.1%
Baseline SDAI=5; Study Day 14 SDAI=5
4
  44.4%
Baseline SDAI=6; Study Day 14 SDAI=5
2
  22.2%
Baseline SDAI=6; Study Day 14 SDAI=7
1
  11.1%
Baseline SDAI=7; Study Day 14 SDAI=7
1
  11.1%
39.Secondary Outcome
Title Sjörgen’s Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) to Study Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=4; Study Day 28 SDAI=4
1
  11.1%
Baseline SDAI=5; Study Day 28 SDAI=5
4
  44.4%
Baseline SDAI=6; Study Day 28 SDAI=5
2
  22.2%
Baseline SDAI=6; Study Day 28 SDAI=7
1
  11.1%
Baseline SDAI=7; Study Day 28 SDAI=7
1
  11.1%
40.Secondary Outcome
Title Sjörgen’s Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) to Study Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=4; Study Day 42 SDAI=5
1
  11.1%
Baseline SDAI=5; Study Day 42 SDAI=5
4
  44.4%
Baseline SDAI=6; Study Day 42 SDAI=5
3
  33.3%
Baseline SDAI=7; Study Day 42 SDAI=7
1
  11.1%
41.Secondary Outcome
Title Sjörgen’s Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale
Hide Description Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.
Time Frame Baseline (Study Day 0) to Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Dexamethasone and Placebo Parotid Irrigation Groups are not applicable; Not measured by Body Side.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline SDAI=4; Study Day 56 SDAI=5
1
  11.1%
Baseline SDAI=5; Study Day 56 SDAI=5
4
  44.4%
Baseline SDAI=6; Study Day 56 SDAI=5
3
  33.3%
Baseline SDAI=7; Study Day 56 SDAI=7
1
  11.1%
42.Secondary Outcome
Title Summary Statistics of MRI Scans
Hide Description Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.
Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Visit MRI Normal
5
  55.6%
5
  55.6%
MRI Abnormal, not clinically signficant
4
  44.4%
4
  44.4%
MRI Abnormal, clinically signficant
0
   0.0%
0
   0.0%
Study Day 56 MRI Normal
5
  55.6%
6
  66.7%
MRI Abnormal, not clinically signficant
3
  33.3%
3
  33.3%
MRI Abnormal, clinically signficant
1
  11.1%
0
   0.0%
43.Secondary Outcome
Title Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit
Hide Description Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).
Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Normal; Study Day 56 Normal
4
  44.4%
5
  55.6%
Screening Normal; Study Day 56 Abnormal ncs
0
   0.0%
0
   0.0%
Screening Normal; Study Day 56 Abnormal cs
1
  11.1%
0
   0.0%
Screening Abnormal ncs; Study Day 56 Normal
1
  11.1%
1
  11.1%
Screening Abnormal ncs; Study Day 56 Abnormal ncs
3
  33.3%
3
  33.3%
Screening Abnormal ncs; Study Day 56 Abnormal cs
0
   0.0%
0
   0.0%
Screening Abnormal cs; Study Day 56 Normal
0
   0.0%
0
   0.0%
Screening Abnormal cs; Study Day 56 Abnormal ncs
0
   0.0%
0
   0.0%
Screening Abnormal cs; Study Day 56 Abnormal cs
0
   0.0%
0
   0.0%
44.Secondary Outcome
Title Summary Statistics of Technetium Scans
Hide Description Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.
Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Stage II Screening Visit Normal
4
  44.4%
4
  44.4%
Abnormal
5
  55.6%
5
  55.6%
Study Day 56 Normal
4
  44.4%
5
  55.6%
Abnormal
5
  55.6%
4
  44.4%
45.Secondary Outcome
Title Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit
Hide Description Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.
Time Frame Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Normal; Study Day 56 Normal
4
  44.4%
4
  44.4%
Baseline Normal; Study Day 56 Abnormal
0
   0.0%
0
   0.0%
Baseline Abnormal; Study Day 56 Normal
0
   0.0%
1
  11.1%
Baseline Abnormal; Study Day 56 Abnormal
5
  55.6%
4
  44.4%
46.Secondary Outcome
Title Summary Statistics of Focus Score
Hide Description Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).
Time Frame Stage II screening (within 6 wks before baseline) through 56 days post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 4 4
Overall Number of Units Analyzed
Type of Units Analyzed: Parotid gland on right side of mouth
4 4
Median (Full Range)
Unit of Measure: score on a scale
Stage II Screening Number Analyzed 4 Parotid gland on right side of mouth 4 Parotid gland on right side of mouth
2.5
(1 to 12)
1.5
(0 to 2)
Study Day 56 Number Analyzed 3 Parotid gland on right side of mouth [1]  4 Parotid gland on right side of mouth
1
(0 to 3)
0.5
(0 to 5)
[1]
3 participants
47.Secondary Outcome
Title Shift Table of Focus Scores From Stage II Screening to Study Day 56
Hide Description Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.
Time Frame Stage II Screening (within 6 wks before baseline) through 56 days post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.
Arm/Group Title Dexamethasone Irrigation of Parotid Gland Placebo Irrigation of Parotid Gland
Hide Arm/Group Description:
Parotid salivary gland on the side of the mouth that received dexamethasone irrigation on study Day 0 and study Day 28.
Parotid salivary gland on the side of the mouth that received placebo irrigation on study Day 0 and study Day 28.
Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Focus=0; Day 56 Focus=0
0
   0.0%
1
  25.0%
Screening Focus=1; Day 56 Focus=1
1
  20.0%
1
  25.0%
Screening Focus=2; Day 56 Focus=0
1
  20.0%
1
  25.0%
Screening Focus=2; Day 56 Focus=5
0
   0.0%
1
  25.0%
Screening Focus=3; Day 56 Focus=not done
1
  20.0%
0
   0.0%
Screening Focus=12; Day 56 Focus=3
1
  20.0%
0
   0.0%
Screening Focus=not done; Day 56 Focus=not done
1
  20.0%
0
   0.0%
Time Frame Treatment emergent adverse events (AEs) are being reported in this document. Reporting period was 71 days from Randomization (Study Day 0) through Safety Follow-up (71 days).
Adverse Event Reporting Description Adverse events were graded according to a descriptive scale based on the NIAID Division of Acquired Immunodeficiency Syndrome Table for Grading the Severity of Adverse Events. Adverse events were summarized by parotid treatment when related to the side of the mouth of parotid irrigation; otherwise, adverse events were summarized as not related to side of the mouth.
 
Arm/Group Title Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
Hide Arm/Group Description Adverse event from the side of the mouth that received the parotid dexamethasone irrigation Adverse event from the side of the mouth that received the parotid placebo irrigation Side of mouth is not applicable to the adverse event
All-Cause Mortality
Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Irrigation Placebo Irrigation Side of Mouth Not Applicable
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)