Clinical trial · Interventional
Treatment for Chronic Pain in Patients With Advanced Cancer
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
NCT00003687CI-TRIAL-00044443completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dextromethorphan hydrobromide | Drug | — | UNRESOLVED |
| morphine sulfate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTMacDonald S, Dudgeon DJ, Bruera E, et al.: 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. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1521, 2002.
- RESULTDudgeon DJ, Bruera E, Gagnon B, Watanabe SM, Allan SJ, Warr DG, MacDonald SM, Savage C, Tu D, Pater JL. A phase III randomized, double-blind, placebo-controlled study evaluating dextromethorphan plus slow-release morphine for chronic cancer pain relief in terminally ill patients. J Pain Symptom Manage. 2007 Apr;33(4):365-71. doi: 10.1016/j.jpainsymman.2006.09.017. PMID 17397698