At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
In Brief
A Phase 3 clinical trial evaluating doxepin hydrochloride oral solution, DLA (diphenhydramine, lidocaine and antacids) rinse, and 1 other intervention for Acute Oral Mucositis Pain. Completed, enrolled 275 participants across 350 sites.
Detailed 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.
Study Details
Timeline
Interventions
2.5 mL (25 mg) doxepin and 2.5 mL water administered orally
5.0 mL administered orally
2.5 mL placebo and 2.5 mL water administered orally