CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Placebo +2 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/NCT02085460
NCT02085460Phase 2Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Mar 12, 2014·Updated Oct 18, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo, 2% Rebamipide liquid, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 94 participants across 5 sites.

Detailed Summary

To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 12, 2014
Enrollment StartMar 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.3 years ago

Interventions

Placebodrug

2% Rebamipide liquiddrug

4% Rebamipide liquiddrug