NCT00003686

Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition. PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids.

Detailed description

OBJECTIVES: I. Evaluate the effectiveness of daily oral pilocarpine versus placebo in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks by comparing proportion of patients with at least one response during the 2 week period, time of first response, and duration of first response. II. Evaluate the adverse effects of pilocarpine in these patients. III. Evaluate whether constipation, sedation, poor appetite, and nausea are ameliorated by pilocarpine in these patients. IV. Evaluate the effect of pilocarpine on quality of life of this patient group. V. Determine the timing and duration of the effect of pilocarpine in this patient population. OUTLINE: This is a randomized, double-blind, multicenter study. Patients receive either oral pilocarpine four times daily (arm I) or oral placebo four times daily (arm II) for 4 weeks. At the end of the 4 weeks, all patients are given the option to receive oral pilocarpine. Quality of life is assessed 2 days prior to randomization, after 2 weeks of treatment, and after 4 weeks of treatment. PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 18 months.

Conditions

• Oral Complications
• Quality of Life

Interventions

Type	Name	Description
DRUG	pilocarpine hydrochloride	Pilocarpine 5 mg po qid x 4 weeks
DRUG	Placebo	Placebo 5 mg po qid x 4 weeks

Timeline

• Start date: 1998-05-22
• Primary completion: 2007-11-01
• Completion: 2008-12-15
• First posted: 2004-08-17
• Last updated: 2020-04-03

Locations

2 sites across 1 country: Canada