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 

Condition(s) targeted: Acute Low Back Pain

Intervention: Combination drug (Acetaminophen + Tramadol) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Labopharm Inc.

Overall contact:
Olga Uresandi, Phone: 18886861017

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. 

Study design: Treatment

Primary outcome: Pain Intensity change from Baseline

Secondary outcome:

Overall satisfaction with the study medication

Safety evaluation

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Olga Uresandi, Phone: 18886861017

Quebec J9A1K7, Canada; Recruiting

Quebec G1G4A2, Canada; Recruiting

Quebec G1V4X7, Canada; Recruiting

Montgomery, Alabama 36117, United States; Recruiting

Centennial, Colorado 80112, United States; Recruiting

Hialeah, Florida 33013, United States; Recruiting

Waterloo, Iowa 50702, United States; Recruiting

Brockton, Massachusetts 02301, United States; Recruiting

Minneapolis, Minnesota 55415, United States; Recruiting

Bathurst, New Brunswick E2A4X7, Canada; Recruiting

Mount Pearl, Newfoundland and Labrador A1N1W7, Canada; Recruiting

Oklahoma City, Oklahoma 73112, United States; Recruiting

Toronto, Ontario M9W4L6, Canada; Recruiting

Newmarket, Ontario L3Y7V1, Canada; Recruiting

Montreal, Quebec H1S3A9, Canada; Recruiting

Cowansville, Quebec J2K2X9, Canada; Recruiting

Drummondville, Quebec J2B7T1, Canada; Recruiting

Trois-Rivieres, Quebec G8T7A1, Canada; Recruiting

Granby, Quebec J2G8Z9, Canada; Recruiting

Sherbrooke, Quebec J1H1Z1, Canada; Recruiting

Pointe-Claire, Quebec H9R4S3, Canada; Recruiting

Mirabel, Quebec J7J2K8, Canada; Recruiting

Rapid City, South Dakota 57702, United States; Recruiting

Crossville, Tennessee 38555, United States; Recruiting

Bryan, Texas 77074, United States; Recruiting

Houston, Texas 77074, United States; Recruiting

Salt Lake City, Utah 84121, United States; Recruiting

Salt Lake City, Utah 84109, United States; Recruiting

Starting date: March 2008
Last updated: August 26, 2008