NCT04986501

Clinical Evaluation of MucoPEG™ for Xerostomia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: SunBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Mouth
• Xerostomia

Interventions

Type	Name	Description
DEVICE	MucoPEG	Experimental
DEVICE	Biotene	Active Comparator

Timeline

• Start date: 2022-05-02
• Primary completion: 2022-09-15
• Completion: 2022-11-15
• First posted: 2021-08-02
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study