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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643383
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Low Back Pain Drug: Combination drug (Acetaminophen + Tramadol) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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



Primary Outcome Measures :
  1. Pain Intensity change from Baseline

Secondary Outcome Measures :
  1. Overall satisfaction with the study medication
  2. Safety evaluation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643383


Locations
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United States, Alabama
Montgomery, Alabama, United States, 36117
United States, Colorado
Centennial, Colorado, United States, 80112
United States, Florida
Hialeah, Florida, United States, 33013
Largo, Florida, United States, 33770
New Port Richey, Florida, United States, 34652
United States, Indiana
Indianapolis, Indiana, United States, 46254
United States, Iowa
Waterloo, Iowa, United States, 50702
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Minnesota
Minneapolis, Minnesota, United States, 55415
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, South Dakota
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Crossville, Tennessee, United States, 38555
United States, Texas
Bryan, Texas, United States, 77082
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77074
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E2A4X7
Canada, Newfoundland and Labrador
Mount Pearl, Newfoundland and Labrador, Canada, A1N1W7
Canada, Ontario
Newmarket, Ontario, Canada, L3Y5G8
Newmarket, Ontario, Canada, L3Y7V1
Sarnia, Ontario, Canada, N7T4X3
Sudbury, Ontario, Canada, P3E1H5
Toronto, Ontario, Canada, M9V4B4
Toronto, Ontario, Canada, M9W4L6
Canada, 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
Canada
Quebec, Canada, G1G4A2
Quebec, Canada, G1V4X7
Sponsors and Collaborators
Labopharm Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00643383    
Other Study ID Numbers: 06CCL3-001
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants