Overview

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.