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| Sponsored by: |
National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003687 |
Purpose
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.
| Condition | Intervention | Phase |
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Pain Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dextromethorphan hydrobromide Drug: morphine sulfate |
Phase III |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| ChemIDplus related topics: | Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| 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 |
| Study Start Date: | December 1998 |
OBJECTIVES:
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.
Patients complete a pain diary twice each day during treatment.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |||||
| Cross Cancer Institute | |||||
| Edmonton, Alberta, Canada, T6G 1Z2 | |||||
| Canada, Newfoundland and Labrador | |||||
| Newfoundland Cancer Treatment and Research Foundation | |||||
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |||||
| Canada, Ontario | |||||
| Princess Margaret Hospital | |||||
| Toronto, Ontario, Canada, M5G 2M9 | |||||
| Canada, Quebec | |||||
| McGill University | |||||
| Montreal, Quebec, Canada, H2W 1S6 | |||||
| National Cancer Institute of Canada |
| Study Chair: | Eduardo Bruera, MD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| MacDonald 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. |
| Study ID Numbers: | CDR0000066789, CAN-NCIC-SC17 |
| First Received: | November 1, 1999 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003687 |
| Health Authority: | United States: Federal Government |
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