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Clinical Evaluation of MucoPEG™ for Xerostomia (CEMPEG)

Primary Purpose

Dry Mouth, Xerostomia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MucoPEG

Biotene

About this trial

This is an interventional treatment trial for Dry Mouth focused on measuring Dry mouth, Xerostomia, Cotton mouth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Must have read, understood and signed an informed consent prior to entering the study.
Must be 18 years of age or older
Good general and mental health with, in the opinion of the investigator or their medically qualified designee, no clinically relevant or significant abnormalities found on examination of the oral cavity or in their medical history.
Participant with a Challacombe Scale score of 1 or higher
Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits
Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits
Participant agrees not to consume any food or liquid during the study visits, except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
Participant agrees to using clinical oral care supplies provided by the investigators and no other products during the entire study
Understands and is willing and able to comply with all study procedures and restrictions

Exclusion Criteria:

Women who are pregnant or intending to become pregnant over the course of the study, or who are found to have a positive urine pregnancy test at the Screening Visit
Women who are breast-feeding
Participant is currently undergoing radiotherapy and/or chemotherapy.
Any condition the investigator identifies that may impede the participant's ability to properly participate in the study. For example, Alzheimer's Disease
Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. For example, presence of oral ulceration.
Evidence of gross intra-oral neglect or need for extensive dental therapy
Denture wearer (complete dentures)
Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry mouth, but the dose requirement of which is unstable
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or to any of their stated ingredients
Participation in another clinical study (including studies of cosmetic products) or in receipt of an investigational drug within 14 days of the screening visit
Previous participation in this study
Recent history (within one year prior to screening visit) of alcohol or other substance abuse

Sites / Locations

ColoradoENT
Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MucoPEG

Biotene

Arm Description

Arm being compared to against Biotene

Arm being compared against MucoPEG

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)

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"

Dry Mouth Relief Questionnaires (DMRQ)

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 Dry Mouth Relief Questionnaires (DMRQ).

Secondary Outcome Measures

Product Use Questionnaire (PPUQ)

To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Use Questionnaire (PPUQ).

Product Performance and Attributes Questionnaire (PPAQ)

To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Performance and Attributes Questionnaire (PPAQ)

Number of participants with treatment-related adverse events as evaluated by the Principal Investigator

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

Change in Xerostomia using the Dry Mouth Inventory (DMI) questionnaire.

To examine change in Xerostomia using the Dry Mouth Inventory (DMI). Using a scale from "Disagree (0)" to "Strongly agree (3)"

Visual Analogue Scale (VAS)

To assess the effectiveness of MucoPEG in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). Where 0 is "Not Dry at All" and 10 is "Very Dry"

Full Information

NCT ID

NCT04986501

First Posted

July 8, 2021

Last Updated

April 10, 2023

Sponsor

SunBio, Inc.

Collaborators

NAMSA, Rudacure

1. Study Identification

Unique Protocol Identification Number

NCT04986501

Brief Title

Clinical Evaluation of MucoPEG™ for Xerostomia

Acronym

CEMPEG

Official Title

Clinical Evaluation of MucoPEG™ for Xerostomia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 2, 2022 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SunBio, Inc.

Collaborators

NAMSA, Rudacure

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of the oral rinse comparing to MucoPEG™ and Biotene®. This is a randomized open-label crossover study with 42 patients receiving treatment. Patients will be randomly assigned to receive either the MucoPEG™ or the Biotene® Dry Mouth Gentle Oral Rinse in the first period. Patients will use the assigned oral rinse two times a day for two weeks. Patients will switch to the other treatment after a wash-out period of one week.

Detailed Description

The purpose of this study is to compare MucoPEG™ and it temporal change to those of the Biotene® Dry Mouth Gentle Oral Rinse in patients with Xerostomia. The study will gather data on patient reported outcomes on the safety and performance of the product, mouth-feel qualities and any changes in dry mouth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Mouth, Xerostomia

Keywords

Dry mouth, Xerostomia, Cotton mouth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The study is a randomized, open-labelled crossover trial.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MucoPEG

Arm Type

Experimental

Arm Description

Arm being compared to against Biotene

Arm Title

Biotene

Arm Type

Active Comparator

Arm Description

Arm being compared against MucoPEG

Intervention Type

Device

Intervention Name(s)

MucoPEG

Intervention Description

Experimental

Intervention Type

Device

Intervention Name(s)

Biotene

Intervention Description

Active Comparator

Primary Outcome Measure Information:

Title

Visual Analogue Scale (VAS)

Description

Time Frame

Prior to product use, first day of treatment period, after the last dose of the product used and on the final day of treatment period.

Title

Dry Mouth Relief Questionnaires (DMRQ)

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Product Use Questionnaire (PPUQ)

Description

To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Use Questionnaire (PPUQ).

Time Frame

2 weeks

Title

Product Performance and Attributes Questionnaire (PPAQ)

Description

To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Performance and Attributes Questionnaire (PPAQ)

Time Frame

2 weeks

Title

Number of participants with treatment-related adverse events as evaluated by the Principal Investigator

Description

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

Time Frame

2 weeks

Title

Change in Xerostomia using the Dry Mouth Inventory (DMI) questionnaire.

Description

To examine change in Xerostomia using the Dry Mouth Inventory (DMI). Using a scale from "Disagree (0)" to "Strongly agree (3)"

Time Frame

2 weeks

Title

Visual Analogue Scale (VAS)

Description

To assess the effectiveness of MucoPEG in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). Where 0 is "Not Dry at All" and 10 is "Very Dry"

Time Frame

2 hours and 1 week of use

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must have read, understood and signed an informed consent prior to entering the study. Must be 18 years of age or older Good general and mental health with, in the opinion of the investigator or their medically qualified designee, no clinically relevant or significant abnormalities found on examination of the oral cavity or in their medical history. Participant with a Challacombe Scale score of 1 or higher Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits Participant agrees not to consume any food or liquid during the study visits, except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods) Participant agrees to using clinical oral care supplies provided by the investigators and no other products during the entire study Understands and is willing and able to comply with all study procedures and restrictions Exclusion Criteria: Women who are pregnant or intending to become pregnant over the course of the study, or who are found to have a positive urine pregnancy test at the Screening Visit Women who are breast-feeding Participant is currently undergoing radiotherapy and/or chemotherapy. Any condition the investigator identifies that may impede the participant's ability to properly participate in the study. For example, Alzheimer's Disease Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. For example, presence of oral ulceration. Evidence of gross intra-oral neglect or need for extensive dental therapy Denture wearer (complete dentures) Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry mouth, but the dose requirement of which is unstable Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or to any of their stated ingredients Participation in another clinical study (including studies of cosmetic products) or in receipt of an investigational drug within 14 days of the screening visit Previous participation in this study Recent history (within one year prior to screening visit) of alcohol or other substance abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

To be determined To be determined, DDS

Organizational Affiliation

Study Site

Official's Role

Principal Investigator

Facility Information:

Facility Name

ColoradoENT

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80923

Country

United States

Facility Name

Tufts University School of Dental Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Evaluation of MucoPEG™ for Xerostomia

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