Trial Outcomes & Findings for Clinical Evaluation of MucoPEG™ for Xerostomia (NCT NCT04986501)

Last Updated: 2025-05-23

Results Overview

To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before).

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

baseline and 2 weeks, value at 2weeks minus value at baseline

Results posted on

2025-05-23

Participant Flow

The study prospectively enrolled 45 subjects from 2 investigational sites across the USA starting 3 MAY 2022. Twenty-two subjects were enrolled, with twenty-one completing the study at Tufts University School of Dental Medicine in Boston, MA, over approximately 42 days. Twenty-three subjects were enrolled, with twenty-one completing the study at Colorado ENT \& Allergy in Colorado Springs, CO.

42 subjects were randomized. 3 subjects were not randomized. why the subjects (n = 3) exited the study early, were screen failure, withdrawal of consent, and lost of follow-up before randomization.

Participant milestones

Participant milestones
Measure	MucoPEG First, Then Biotène® Participants first used MucoPEG two times a day, once after breakfast and once before bedtime for 2 weeks. After a washout period of 1 weeks, they then used Biotene two times a day for 2 weeks.	BIotene First, Then MucoPEG Participants first used Biotene two times a day for 2 weeks. After a washout period of 1 weeks, they then used MucoPEG two times a day, once after breakfast and once before bedtime for 2 weeks.
First Intervention(2 Weeks) STARTED	20	22
First Intervention(2 Weeks) COMPLETED	20	22
First Intervention(2 Weeks) NOT COMPLETED	0	0
Second Intervention(2 Weeks) STARTED	20	22
Second Intervention(2 Weeks) COMPLETED	20	22
Second Intervention(2 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of MucoPEG™ for Xerostomia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=42 Participants Participant will be randomly allocated to either MucoPEG or Biotene in this crossover study in a 1:1 ratio. Participants first received MucoPEG or Biotene for 2 weeks. After a washout period of 1 weeks, they then received Biotene or MucoPEG for 2 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Challacombe Scale Score	3.3 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 2 weeks, value at 2weeks minus value at baseline

Population: Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.

Outcome measures

Outcome measures
Measure	MucoPEG n=42 Participants Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 Participants Arm being compared against MucoPEG Biotene: Active Comparator
Change in VAS for Mouth Dryness Period 1	-0.8 score on a scale Standard Deviation 2.0	-0.7 score on a scale Standard Deviation 3.0
Change in VAS for Mouth Dryness Period 2	-1.5 score on a scale Standard Deviation 2.4	-0.4 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 2 weeks(at last visit)

The effect of MucoPEG™ in relieving xerostomia, relative to that of Biotène was assessed using the Dry Mouth Relief Questionnaires (DMRQ). This questionnaire was given to the patients to answer the following question: "Does the product relieve the discomfort of dry mouth?" To answer the question, only one of the answer options is selected: 1. None/ (No Relief), 2. Not Enough, 3. Some/ Good, 4. Very Good, 5. Significant/ Excellent A favorable responses on the Dry Mouth Relief Questionnaire (DMRQ) include "4 - very good" or "5 - significant/excellent." The numbers are the number of patients who responded favorably at their last visit.

Outcome measures

Outcome measures
Measure	MucoPEG n=42 Participants Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 Participants Arm being compared against MucoPEG Biotene: Active Comparator
Dry Mouth Relief Questionnaires (DMRQ)	10 participants response with 4 or 5 score	11 participants response with 4 or 5 score

PRIMARY outcome

Timeframe: baseline and 2 weeks, value at 2weeks minus value at baseline

Outcome measures

Outcome measures
Measure	MucoPEG n=42 Participants Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 Participants Arm being compared against MucoPEG Biotene: Active Comparator
Change in VAS for Tongue Dryness Period 1	-0.6 score on a scale Standard Deviation 2.4	-0.4 score on a scale Standard Deviation 3.3
Change in VAS for Tongue Dryness Period 2	-1.4 score on a scale Standard Deviation 2.4	-0.2 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 2 weeks

To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator.

Outcome measures

Outcome measures
Measure	MucoPEG n=42 Participants Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 Participants Arm being compared against MucoPEG Biotene: Active Comparator
Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 weeks

To demonstrate the effectiveness using the Dry Mouth Inventory (DMI). There are 8 Dry Mouth Inventory (DMI) questionaires as follows. 1. My mouth feels dry, 2. I have difficulty eating dry foods, 3. I get up at night to drink, 4. My mouth feels dry when eating a meal, 5. I sip liquids to aid in swallowing food, 6. I suck sweets or cough lollies to relieve dry mouth, 7. My lips stick to the teeth, 8. My tongue sticks to the roof of my mouth. Using a scale from "Disagree (0)" to "Strongly agree (3)". The scale has a minimum value of "0" and a maximum value of "24". The larger the scale, the more severe the dry mouth.

Outcome measures

Outcome measures
Measure	MucoPEG n=42 Participants Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 Participants Arm being compared against MucoPEG Biotene: Active Comparator
Dry Mouth Inventory (DMI) Questionnaire.	9.4 score on a scale Standard Deviation 5.3	9.4 score on a scale Standard Deviation 5.6

Adverse Events

MucoPEG

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Biotene

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MucoPEG n=42 participants at risk Arm being compared to against Biotene MucoPEG: Experimental	Biotene n=42 participants at risk Arm being compared against MucoPEG Biotene: Active Comparator
Gastrointestinal disorders celiac disease	0.00% 0/42 • Adverse event data were collected at treatment period (35days)	2.4% 1/42 • Number of events 1 • Adverse event data were collected at treatment period (35days)
General disorders Food reaction	2.4% 1/42 • Number of events 1 • Adverse event data were collected at treatment period (35days)	0.00% 0/42 • Adverse event data were collected at treatment period (35days)
Infections and infestations sinus infection	0.00% 0/42 • Adverse event data were collected at treatment period (35days)	2.4% 1/42 • Number of events 1 • Adverse event data were collected at treatment period (35days)

Additional Information

Min-Jung Ahn

Sunbio

Phone: +82-31-423-5467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place