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NeutraSal Treatment for Xerostomia in OSAS Patients Using CPAP Therapy

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ClinicalTrials.gov Identifier: NCT02107300
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Invado Pharmaceuticals LLC
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Xerostomia
Interventions Drug: NeutraSal
Drug: Placebo Comparator
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NeutraSal Placebo
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NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Period Title: Overall Study
Started 16 15
Completed 16 15
Not Completed 0 0
Arm/Group Title NeutraSal Placebo Total
Hide Arm/Group Description

NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
53.5
(27 to 80)
54
(37 to 71)
53.5
(27 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
12
  75.0%
11
  73.3%
23
  74.2%
Male
4
  25.0%
4
  26.7%
8
  25.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
16
 100.0%
15
 100.0%
31
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
16
 100.0%
15
 100.0%
31
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16 15 31
Overall Number of Baseline Participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
16
 100.0%
15
 100.0%
31
 100.0%
1.Primary Outcome
Title Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage
Hide Description To observe the impact of NeutraSal on OSAS (obstructive sleep apnoea syndrome) patients compliance to CPAP (Continuous Positive Airway Pressure) therapy compared to placebo. CPAP usage is determined by % of nights CPAP use was greater than 4 hours.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NeutraSal Placebo
Hide Arm/Group Description:

NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: percentage of time
-5.09  (.27) 11.67  (.16)
2.Secondary Outcome
Title Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire
Hide Description To assess whether the daily use of NeutraSal will prevent or reduce dry mouth perception in OSAS patients undergoing CPAP therapy. Dry Mouth perception will be measured by an Xerostomia Questionnaire which rates mouth dryness. The scale is rated from 1-10 (1 being dry as a desert and 10 is normal)
Time Frame Baseline through 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NeutraSal Placebo
Hide Arm/Group Description:

NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

Overall Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
.61  (2.78) .73  (3.33)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NeutraSal Placebo
Hide Arm/Group Description

NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

NeutraSal: NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.

Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.

Placebo Comparator: Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal

All-Cause Mortality
NeutraSal Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NeutraSal Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NeutraSal Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/16 (43.75%)      6/15 (40.00%)    
Gastrointestinal disorders     
Stomach pain *  0/16 (0.00%)  0 2/15 (13.33%)  2
General disorders     
Neutrasal drug related * [1]  3/16 (18.75%)  3 0/15 (0.00%)  0
Neck stiffness *  0/16 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  1/16 (6.25%)  1 0/15 (0.00%)  0
URI *  0/16 (0.00%)  0 3/15 (20.00%)  3
URI and aphthoid ulcer *  1/16 (6.25%)  1 0/15 (0.00%)  0
URI and sinus infection *  1/16 (6.25%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders     
Shingles *  1/16 (6.25%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Reported salty taste, dry mouth because of drug
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chitra Lal
Organization: Medical University of South Carolina
Phone: (843) 792-7776
EMail: lalch@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02107300     History of Changes
Other Study ID Numbers: CPAP
First Submitted: March 28, 2014
First Posted: April 8, 2014
Results First Submitted: July 11, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018