Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

Phase 3

Terminated

• Conditions: Oral Complications; Quality of Life
• Interventions: Drug: Placebo; Drug: pilocarpine hydrochloride

• Registration Number: NCT00003686
• Lead Sponsor: NCIC Clinical Trials Group

Brief 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.

Study Timeline

• Study Start: 1998-05-22
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-08-16
• Study First Posted: 2004-08-17
• Primary Completion: 2007-11-01
• Study Completion: 2008-12-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pilocarpine	pilocarpine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Efficacy	10 years	To evaluate, using a 100 mm VAS, the effectiveness of oral pilocarpine 5 mg qid in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks (day 15). This will include comparing the proportion of at least one response during the 2 week period, time to first response and duration of first response.

Trial Locations

Locations (2)

BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Humber River Regional Hospital; 🇨🇦 Weston, Ontario, Canada