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A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth (NCT00003686)

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.
  • Drug: pilocarpine hydrochloride
    Pilocarpine 5 mg po qid x 4 weeks
    • Drug: Placebo
      Placebo 5 mg po qid x 4 weeks
      Ages eligible for Study
      16 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.

      2 locations

      Canada (2)
      • BC Cancer Agency
        Not specified
        Vancouver, British Columbia, Canada, V5Z 4E6
      • Humber River Regional Hospital
        Not specified
        Weston, Ontario, Canada, M9N 1N8
      Status:
      terminated
      Type:
      Interventional
      Phase:
      Start:
      31 July, 1998
      Updated:
      29 May, 2013
      Participants:
      4
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