A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain
NCT ID: NCT00643383
Last Updated: 2012-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2008-03-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Combination drug (Acetaminophen + Tramadol)
2
Placebo
Interventions
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Combination drug (Acetaminophen + Tramadol)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Current acute low back pain episode within 48h prior to study entry.
* Pain must be moderate to severe following incident
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Labopharm Inc.
INDUSTRY
Responsible Party
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Locations
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Montgomery, Alabama, United States
Centennial, Colorado, United States
Hialeah, Florida, United States
Largo, Florida, United States
New Port Richey, Florida, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Baton Rouge, Louisiana, United States
Brockton, Massachusetts, United States
Minneapolis, Minnesota, United States
Oklahoma City, Oklahoma, United States
Rapid City, South Dakota, United States
Crossville, Tennessee, United States
Bryan, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Bathurst, New Brunswick, Canada
Mount Pearl, Newfoundland and Labrador, Canada
Greater Sudbury, Ontario, Canada
Newmarket, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Cowansville, Quebec, Canada
Drummondville, Quebec, Canada
Gatineau, Quebec, Canada
Granby, Quebec, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Countries
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References
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Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, Robertson S. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Curr Med Res Opin. 2012 May;28(5):847-57. doi: 10.1185/03007995.2012.681035. Epub 2012 Apr 25.
Other Identifiers
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NCT00643383
Identifier Type: REGISTRY
Identifier Source: secondary_id
06CCL3-001
Identifier Type: -
Identifier Source: org_study_id
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