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Completed

NCT Number: NCT00643383

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

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.

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Key information

Conditions

Acute Low Back Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bathurst, New Brunswick, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination drug (Acetaminophen + Tramadol)

Drug

Placebo

Drug

Primary outcomes

  1. Pain Intensity change from Baseline

Secondary outcomes

  1. Overall satisfaction with the study medication

  2. Safety evaluation

Sponsors and collaborators

Lead sponsor

Labopharm Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 26, 2008
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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