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

Status and phase

Completed

Phase 3

Conditions

Acute Low Back Pain

Treatments

Drug: Combination drug (Acetaminophen + Tramadol)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00643383

06CCL3-001

NCT00643383 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

277 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.