NCT00017511

Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.

Detailed description

OBJECTIVES: * Compare the efficacy of cevimeline vs placebo, in terms of dryness of the oral cavity and salivary flow, in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region. * Assess the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity. * Arm II: Patients receive oral placebo as in arm I. PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.

Conditions

• Head and Neck Cancer
• Oral Complications
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	cevimeline hydrochloride

Timeline

• Start date: 2001-06-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2003-01-27
• Last updated: 2012-05-16

Locations

71 sites across 1 country: United States