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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

NCT00051441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2011-05-19

No results posted yet for this study

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

Conditions

Interventions

DRUG

Benzydamine Hydrochloride 0.15% Oral Rinse

Sponsors & Collaborators

  • Angelini

    collaborator INDUSTRY

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    lead INDUSTRY

Principal Investigators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2005-02-28

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00051441 on ClinicalTrials.gov