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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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) )

Brief Summary:

Background:

Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works.

Objectives:

- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome.

Eligibility:

- Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.

Design:

  • Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.
  • At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.
  • Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.
  • Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.
  • Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Xerostomia Drug: Dexamethasone Parotid Irrigation Drug: Placebo Parotid Irrigation Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
Study Start Date : May 1, 2011
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017


Arm Intervention/treatment
Placebo Comparator: Placebo Parotid Irrigation
Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency}
Drug: Placebo Parotid Irrigation
Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.

Experimental: Dexamethasone Parotid Irrigation
Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency}
Drug: Dexamethasone Parotid Irrigation
Irrigation of the parotid gland from one side of the mouth with dexamethasone.
Other Name: Placebo Parotid Irrigation




Primary Outcome Measures :
  1. Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56. [ Time Frame: Baseline (Study Day 0) to Study Day 56 ]
    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.


Secondary Outcome Measures :
  1. Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14. [ Time Frame: Baseline to 14 days post-baseline ]
    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.

  2. Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28. [ Time Frame: Baseline to 28 days post-baseline ]
    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.

  3. Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42. [ Time Frame: Baseline to 42 days post-baseline ]
    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.

  4. Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  5. Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  6. Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  7. Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  8. Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify: [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

  9. Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  10. 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: [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

  11. Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  12. Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify: [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.

  13. Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  14. Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  15. Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be: [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  16. Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  17. Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

  18. Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  19. Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  20. Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

  21. Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  22. Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  23. Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

  24. Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56

  25. Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale) [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Ordinal Scale 0:least to 10:greatest level of disease activity

  26. Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Nominal scale values: Inactive; Low; Moderate; High

  27. Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'? [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Response: Yes or No

  28. 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 [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Ordinal Scale 0: least to 10: greatest level of disease activity.

  29. Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now: [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Nominal Scale: Much better; Better; The same; Worse; Much worse

  30. 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): [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Response: Yes; No

  31. 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. [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    Possible Response: Yes or No

  32. Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores [ Time Frame: Baseline (Study Day 0) through Study Day 14 ]
    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.

  33. Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores [ Time Frame: Baseline (Study Day 0) through Study Day 28 ]
    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.

  34. Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores [ Time Frame: Baseline (Study Day 0) through Study Day 42 ]
    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.

  35. Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores [ Time Frame: Baseline (Study Day 0) through Study Day 56 ]
    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.

  36. 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 [ Time Frame: Baseline (Study Day 0) to Study Day 56 ]
    Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.

  37. 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 [ Time Frame: Baseline (Study Day 0) to Study Day 14 ]
    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.

  38. 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 [ Time Frame: Baseline (Study Day 0) to Study Day 28 ]
    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.

  39. 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 [ Time Frame: Baseline (Study Day 0) to Study Day 42 ]
    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.

  40. 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 [ Time Frame: Baseline (Study Day 0) to Study Day 56 ]
    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.

  41. Summary Statistics of MRI Scans [ Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 ]
    Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.

  42. Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit [ Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 ]
    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).

  43. Summary Statistics of Technetium Scans [ Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 ]
    Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.

  44. Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit [ Time Frame: Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56 ]
    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.

  45. Summary Statistics of Focus Score [ Time Frame: Stage II screening (within 6 wks before baseline) through 56 days post-baseline ]
    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).

  46. Shift Table of Focus Scores From Stage II Screening to Study Day 56 [ Time Frame: Stage II Screening (within 6 wks before baseline) through 56 days post-baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Female gender and age 18 and greater.
  • Diagnosed with primary SS in Protocol 84-D-0056.
  • Stimulated salivary flow of at least 0.01 mL/min from each parotid gland, using the standard operating procedure (SOP) for the National Institute of Dental and Craniofacial Research (NIDCR) Molecular Physiology and Therapeutics Branch (MPTB) Sjögren's Syndrome Clinic
  • Minor salivary gland (MSG) biopsy with a focus score of greater than or equal to 1 obtained 0 to 7 years prior to study enrollment. Biopsies from outside of the National Institutes of Health (NIH) must be reviewed by the NIH Pathology Department. An MSG biopsy will be required for the following situations:
  • The last biopsy was obtained before the use of rituximab.
  • The last biopsy was obtained before the use of immunosuppressants, biologics, or disease-modifying antirheumatic drugs for more than 3 months.
  • The last biopsy was obtained before the use of systemic corticosteroids (for more than 2 weeks or for shorter periods at doses of more than 0.5 mg/kg) or local parotid corticosteroids. The use of topical or intra-articular/periarticular corticosteroids will not require a repeat biopsy.
  • For women of childbearing potential, use of, or willingness to use, an effective method of birth control during the study. Effective methods include abstinence, history of hysterectomy, tubal ligation, intrauterine device, licensed hormonal methods, condoms, diaphragm, and cervical cap.
  • Ability to provide written informed consent prior to entry in the study.

EXCLUSION CRITERIA:

  • History of lymphoma.
  • History of mycosis, aspergillosis, or other deep fungal infection of the parotid gland.
  • History of salivary gland malignancy (primary or metastatic to the salivary gland).
  • History of secondary Sjögren's syndrome.
  • Parotid infection that does not resolve at least 4 weeks before the start of the Screening Period.
  • Any active viral infection that does not resolve by the start of the Screening Period.
  • Pregnancy or lactation.
  • Use of biologics within 3 months of the start of the Screening Period.
  • Any experimental therapy within 3 months before the start of the Screening Period.
  • Use of immunosuppressants such as methotrexate, leflunomide, azathioprine, cyclophosphamide, systemic cyclosporine, or systemic corticosteroids within 3 months prior to the start of the Screening Period.
  • Use of inhaled corticosteroids within 3 months prior to the start of the Screening Period.
  • Use of antimalarials and regular use of NSAIDs unless the dose has been stable (or decreased) for at least 2 months.
  • Inability to discontinue the use of saliva stimulants such as pilocarpine and cevimeline for 24 hours before each study visit.
  • Parotid intraductal irrigation or instillation with steroids within the past year.
  • Use of rituximab within 6 months prior to the start of the Screening Period.
  • Allergy to steroids or technetium, or any components of the formulations.
  • Current use of warfarin or heparin.
  • History of bleeding disorder.
  • Both severe atrophy and fibrosis of the MSG noted on the pathology report of the MSG biopsy.
  • Inability to comply with protocol procedures and the number of required visits.
  • Inability to cannulate one or both parotid glands.
  • Parotid fill volume less than 0.5 mL in one or both parotid glands.
  • Significant concurrent medical condition or other circumstances that, in the opinion of the principal investigator, could affect the subject's ability to tolerate or complete the study.
  • Unable to understand written English for completion of study questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316770


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  Study Documents (Full-Text)

Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Study Protocol  [PDF] October 1, 2015
Statistical Analysis Plan  [PDF] March 9, 2018


Additional Information:
Publications:
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT01316770     History of Changes
Other Study ID Numbers: 110094
11-D-0094 ( Other Identifier: CNS IRB number )
First Posted: March 16, 2011    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Xerostomia
Sjögren's Syndrome
Interventional Study
Sjogren's Syndrome
Dry Mouth

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Dry Eye Syndromes
Xerostomia
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones