Status:
COMPLETED
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
Lead Sponsor:
Labopharm Inc.
Conditions:
Acute Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00643383
Start Date
March 1 2008
End Date
February 1 2009
Last Update
May 1 2012
Active Locations (38)
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1
Montgomery, Alabama, United States, 36117
2
Centennial, Colorado, United States, 80112
3
Hialeah, Florida, United States, 33013
4
Largo, Florida, United States, 33770