Clinical trial

Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral…

NCT00051441 · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., Industry · Completed

Key facts

NCT number NCT00051441
Title 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
Official title A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects With Radiation-Induced Mucositis
Lead sponsor McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., Industry
Collaborators Angelini Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Stomatitis, Radiation Effects
Intervention type Drug
Interventions Benzydamine Hydrochloride 0.15% Oral Rinse
Enrollment 605
Completion Feb 1, 2005
First posted Jan 13, 2003
Last update posted May 19, 2011

At a glance

  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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