drugset / Trial / NCT00051441
Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx
Phase 3
Completed
605 enrolled
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Angelini · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to compare the effectiveness and safety of benzydamine hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced oral mucositis, and to compare the care normally used for radiation-induced oral mucositis to vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral mucosa
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2005-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benzydamine | Unknown | 0.15 % | Oral |