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NCT02229539 · ClinicalTrials.gov registry record · Phase 3
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
NCT02229539: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT02229539 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 275 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229539, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
Primary Outcome
Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) repla
Interventions
- OTHER Placebo
- DRUG doxepin hydrochloride oral solution
- DRUG DLA (diphenhydramine, lidocaine and antacids) rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2019-03-15 |
| Phase | Phase 3 |
What the finished NCT02229539 record still lists
NCT02229539 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02229539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02229539 about?
NCT02229539 is a clinical study titled "Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy". The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-c...
What is the current status of trial NCT02229539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2014-11-18. Estimated completion is 2019-03-15.
What interventions are being tested in trial NCT02229539?
The interventions under investigation include: Placebo (OTHER), doxepin hydrochloride oral solution (DRUG), DLA (diphenhydramine, lidocaine and antacids) rinse (DRUG).
Who is sponsoring clinical trial NCT02229539?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02229539's enrollment target sits among peer trials
275 1206th of 2000 higher than 794 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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