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
Phase 3
Completed
- Conditions
- Acute Low Back Pain
- Interventions
- Drug: Combination drug (Acetaminophen + Tramadol)Drug: Placebo
- Registration Number
- NCT00643383
- Lead Sponsor
- Labopharm Inc.
- 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 18 and 80 yrs of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Combination drug (Acetaminophen + Tramadol) - 2 Placebo -
- Primary Outcome Measures
Name Time Method Pain Intensity change from Baseline
- Secondary Outcome Measures
Name Time Method Overall satisfaction with the study medication Safety evaluation