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NCT04289051 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of Oral Rinse for Xerostomia
A NA study, sponsored by Sunstar Americas.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT04289051 is a NA study that has completed, run by Sunstar Americas. The registered enrollment target is 39 participants.
The verdict
NCT04289051, a NA study, has completed, sponsored by Sunstar Americas.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market. This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.
Interventions
- DEVICE HYDRAL Oral Rinse
- DEVICE BIOTENE® Oral Rinse
- DEVICE Placebo Oral Rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2021-02-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04289051
The ClinicalTrials.gov registry entry for NCT04289051 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sunstar Americas, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which HYDRAL Oral Rinse is the first listed.
NCT04289051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04289051 about?
NCT04289051 is a clinical study titled "Clinical Evaluation of Oral Rinse for Xerostomia". Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to th...
What is the current status of trial NCT04289051?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2020-08-19. Estimated completion is 2021-02-04.
What interventions are being tested in trial NCT04289051?
The interventions under investigation include: HYDRAL Oral Rinse (DEVICE), BIOTENE® Oral Rinse (DEVICE), Placebo Oral Rinse (DEVICE).
Who is sponsoring clinical trial NCT04289051?
This trial is sponsored by Sunstar Americas, which has 10 total clinical trials registered on ClinicalTrials.gov.
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