Treatment for Chronic Pain in Patients With Advanced Cancer
CompletedPhase 3NCT00003687
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Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: dextromethorphan hydrobromide
- Drug: morphine sulfate
- Sponsor
- NCIC Clinical Trials Group
- Organization
- Canadian Cancer Trials Group
- Start date
- 1998-06-11
- Primary completion
- 2001-09-26
- Sex
- All
- Age range
- from 16 Years to 120 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced cancer with chronic pain * Cancer pain requiring strong opioids having an average pain score of less than 6/10 on the visual analog scale within last 24 hours * Pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least 2 days with no more than 2 breakthrough immediate release morphine doses per 24 hours * Pain that is expected to be controlled by a stable and adequate total daily dose of sustained release morphine for the first 7 days of the study PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Not specified Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * SGOT or SGPT no greater than 3 times upper limit of normal (ULN) * No liver disease Renal: * Creatinine no greater than 2 times ULN * No kidney failure Pulmonary: * No clinically significant respiratory depression * No severe obstructive airway disease Other: * Fluent in English or French * No known hypersensitivity or allergy to study medications or components or other multiple drug allergies * Normal cognition defined by the Folstein Mini-Mental State Questionnaire (at least 24/30 correct) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 14 days since prior chemotherapy Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * At least 14 days since prior analgesic radiotherapy Surgery: * Not specified Other: * At least 3 months since prior investigational agents * At least 1 month since prior clinical study * No concurrent analgesics other than morphine * No other concurrent medications containing dextromethorphan * Concurrent antidepressant medication allowed * Concurrent nonsteroidal antiinflammatory drugs allowed * At least 14 days since prior monoamine oxidase (MAO) inhibitors * No concurrent MAO inhibitors
Canadian sites (4)
| Facility | City | Province |
|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta |
| Newfoundland Cancer Treatment and Research Foundation | St. John's | Newfoundland and Labrador |
| Princess Margaret Hospital | Toronto | Ontario |
| McGill University | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00003687