CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 155 enrolled
Drug / intervention
doxepin hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01156142
NCT01156142Phase 3Completed
CompareCT.gov

A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 2, 2010·Updated Aug 9, 2017

In Brief

A Phase 3 clinical trial evaluating doxepin hydrochloride and placebo for Head and Neck Cancer and 3 related conditions. Completed, enrolled 155 participants across 120 sites.

Detailed Summary

RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy. PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Mucositis, Oral Complications of Radiation Therapy, Pain
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2012
Study CompletionMar 2, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16 years ago

Interventions

doxepin hydrochloridedrug

Oral rinse

placeboother

Oral rinse