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Sponsored by: |
Labopharm Inc. |
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Information provided by: | Labopharm Inc. |
ClinicalTrials.gov Identifier: | NCT00643383 |
A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.
Condition | Intervention | Phase |
---|---|---|
Acute Low Back Pain |
Drug: Combination drug (Acetaminophen + Tramadol) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Parallel Assignment |
Estimated Enrollment: | 250 |
Study Start Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: Combination drug (Acetaminophen + Tramadol) |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Labopharm Inc. ( Sybil Robertson, Vice-President Regulatory Affairs ) |
Study ID Numbers: | 06CCL3-001 |
Study First Received: | March 20, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00643383 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Tramadol Low Back Pain Central Nervous System Depressants Pain Narcotics Back Pain Signs and Symptoms |
Analgesics, Non-Narcotic Neurologic Manifestations Analgesics Peripheral Nervous System Agents Acetaminophen Analgesics, Opioid |
Tramadol Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Low Back Pain Narcotics Pain Back Pain Pharmacologic Actions Signs and Symptoms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid Acetaminophen |