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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: Completed NA study, sponsored by Sunstar Americas.
NCT04289051 is a NA study that has completed, run by Sunstar Americas. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome.
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 |
What the finished NCT04289051 record still lists
NCT04289051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which HYDRAL Oral Rinse is the first listed.
NCT04289051 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04289051's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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