- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003687
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
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eduardo Bruera, MD, M.D. Anderson Cancer Center
Publications and helpful links
General Publications
- 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.
- Dudgeon 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- pain
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- AIDS-related peripheral/systemic lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- small intestine lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- monoclonal gammopathy of undetermined significance
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- chronic idiopathic myelofibrosis
- acute undifferentiated leukemia
- untreated adult acute lymphoblastic leukemia
- meningeal chronic myelogenous leukemia
- progressive hairy cell leukemia, initial treatment
- T-cell large granular lymphocyte leukemia
- untreated hairy cell leukemia
- AIDS-related primary CNS lymphoma
- non-Hodgkin lymphoma during pregnancy
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Hemorrhagic Disorders
- Intestinal Diseases
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Intestinal Neoplasms
- Myeloproliferative Disorders
- Precancerous Conditions
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Dextromethorphan
- Morphine
Other Study ID Numbers
- SC17
- CAN-NCIC-SC17 (Other Identifier: PDQ)
- CDR0000066789 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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