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

April 30, 2012 updated by: Labopharm Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1G4A2
      • Quebec, Canada, G1V4X7
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A4X7
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N1W7
    • Ontario
      • Newmarket, Ontario, Canada, L3Y5G8
      • Newmarket, Ontario, Canada, L3Y7V1
      • Sarnia, Ontario, Canada, N7T4X3
      • Sudbury, Ontario, Canada, P3E1H5
      • Toronto, Ontario, Canada, M9W4L6
      • Toronto, Ontario, Canada, M9V4B4
    • Quebec
      • Cowansville, Quebec, Canada, J2K2X9
      • Drummondville, Quebec, Canada, J2B7T1
      • Gatineau, Quebec, Canada, J9A1K7
      • Granby, Quebec, Canada, J2G8Z9
      • Mirabel, Quebec, Canada, J7J2K8
      • Montreal, Quebec, Canada, H1S3A9
      • Montreal, Quebec, Canada, H4N2W2
      • Pointe-Claire, Quebec, Canada, H9R4S3
      • Sherbrooke, Quebec, Canada, J1H1Z1
      • Trois-Rivieres, Quebec, Canada, G8T7A1
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36117
    • Colorado
      • Centennial, Colorado, United States, 80112
    • Florida
      • Hialeah, Florida, United States, 33013
      • Largo, Florida, United States, 33770
      • New Port Richey, Florida, United States, 34652
    • Indiana
      • Indianapolis, Indiana, United States, 46254
    • Iowa
      • Waterloo, Iowa, United States, 50702
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
    • Tennessee
      • Crossville, Tennessee, United States, 38555
    • Texas
      • Bryan, Texas, United States, 77082
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77074
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Active Comparator: 1
Drug: Combination drug (Acetaminophen + Tramadol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain Intensity change from Baseline

Secondary Outcome Measures

Outcome Measure
Safety evaluation
Overall satisfaction with the study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Labopharm Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06CCL3-001
  • NCT00643383 (Registry Identifier: ClinicalTrials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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