Trials / Completed
CompletedNCT02085460
A 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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | |
| DRUG | 2% Rebamipide liquid | |
| DRUG | 4% Rebamipide liquid |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-03-12
- Last updated
- 2021-10-18
- Results posted
- 2021-04-06
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02085460. Inclusion in this directory is not an endorsement.