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A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients (NCT00003687)

RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain. PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.
  • Drug: dextromethorphan hydrobromide
    • Drug: morphine sulfate
      Ages eligible for Study
      16 Years to 120 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Compare the analgesic efficacy of two formulations of morphine (Statex SR versus MS-Contin) in patients requiring morphine for the treatment of chronic cancer pain.

      - Compare the effect of these 2 formulations of morphine on the total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects experienced in the two treatment groups.

      - Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups (phase B).

      - Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects on the two treatment groups (phase B).

      OUTLINE: This is a randomized, double-blind, parallel-group, multicenter study. Patients are stratified by stabilization dose (less than 120 mg/day vs greater than 120 mg/day of morphine) and institution in phase A, and neuropathic pain (yes vs no) in phase B.

      - Phase A: Patients are randomized to receive oral morphine in one of two formulations (MS Contin or Statex SR) every 12 hours for 7 days.

      - Phase B: Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours, and oral morphine tablets every 12 hours for 14 days.

      - Phase C: All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days.

      Patients complete a pain diary twice each day during treatment.

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

      4 locations

      Canada (4)
      • Cross Cancer Institute
        Edmonton, Alberta, Canada, T6G 1Z2
      • Newfoundland Cancer Treatment and Research Foundation
        St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Princess Margaret Hospital
        Toronto, Ontario, Canada, M5G 2M9
      • McGill University
        Montreal, Quebec, Canada, H2W 1S6
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      30 November, 1998
      Updated:
      24 November, 2016
      Participants:
      0
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