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

Labopharm Inc.0 sites277 target enrollmentMarch 2008

ConditionsAcute Low Back Pain

InterventionsCombination drug (Acetaminophen + Tramadol)Placebo

DrugsCombination drug (Acetaminophen + Tramadol)Placebo

Overview

Phase: Phase 3
Intervention: Combination drug (Acetaminophen + Tramadol)
Conditions: Acute Low Back Pain
Sponsor: Labopharm Inc.
Enrollment: 277
Primary Endpoint: Pain Intensity change from Baseline
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

February 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Labopharm Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.