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...
Date First Received: March 20, 2008
Last Updated: April 2, 2009
Verified by: Labopharm Inc., April 2009
Clinical Trial Phase: Phase 3 | Start Date: March 2008
Overall Status: Completed
Estimated Enrollment: 250
Brief Summary
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Double-Blind, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Combination drug (Acetaminophen + Tramadol)
- Drug: Placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Pain Intensity change from Baseline
Secondary Measures
- Overall satisfaction with the study medication
- Safety evaluation
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Males or females in generally good health aged 18-80 years with moderate to severe acute low back pain.
- Current acute low back pain episode within 48h prior to study entry.
- Pain must be moderate to severe following incident
Exclusion Criteria:
- Chronic low back pain
- Ongoing or history of alcohol or drug abuse
- Body Mass Index greater 39
- Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors
- Known history or symptoms suspicious for cancer
- Significant renal or liver disease
- Spinal surgery within 1 year of study entry.
- Subjects who are pregnant or lactating.
- Subjects with unstable medical disease.
- Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Labopharm Inc.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643383
Study ID Number: 06CCL3-001
ClinicalTrials.gov Identifier: NCT00643383
Health Authority: United States: Food and Drug Administration
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