A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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.
David Warr, MD
Princess Margaret Hospital, Canada
Canada: Health Canada