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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Labopharm Inc.
• Treatments: Acetaminophen; Tramadol

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.