Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 275 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02229539
The ClinicalTrials.gov registry entry for NCT02229539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02229539 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.