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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Low Back Pain

In brief

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.

Key facts

Study ID

NCT00643383

Run by

Labopharm Inc.

People needed

277

Starts

2008-03-01

Expected to finish

2009-02-01

Last updated by the study team

2012-05-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Centennial, Colorado, United States
• Study site — Hialeah, Florida, United States
• Study site — Largo, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Waterloo, Iowa, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Crossville, Tennessee, United States
• Study site — Bryan, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Bathurst, New Brunswick, Canada
• Study site — Mount Pearl, Newfoundland and Labrador, Canada
• Study site — Greater Sudbury, Ontario, Canada
• Study site — Newmarket, Ontario, Canada
• Study site — Newmarket, Ontario, Canada
• Study site — Sarnia, Ontario, Canada
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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