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 - Full Text View

Sponsor:	Labopharm Inc.
Information provided by:	Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00643383

Purpose

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	Intervention	Phase
Acute Low Back Pain	Drug: Combination drug (Acetaminophen + Tramadol) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Tramadol Tramadol hydrochloride Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:

Pain Intensity change from Baseline

Secondary Outcome Measures:

Overall satisfaction with the study medication
Safety evaluation

Estimated Enrollment:	250
Study Start Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator	Drug: Combination drug (Acetaminophen + Tramadol)
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643383

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Locations

United States, Alabama

Montgomery, Alabama, United States, 36117
United States, Colorado

Centennial, Colorado, United States, 80112
United States, Florida

Hialeah, Florida, United States, 33013

New Port Richey, Florida, United States, 34652

Largo, Florida, United States, 33770
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, 77074

Houston, Texas, United States, 77074

Dallas, Texas, United States, 75235
United States, Utah

Salt Lake City, Utah, United States, 84121
Canada

Quebec, Canada, G1G4A2

Quebec, Canada, G1V4X7
Canada, New Brunswick

Bathurst, New Brunswick, Canada, E2A4X7
Canada, Newfoundland and Labrador

Mount Pearl, Newfoundland and Labrador, Canada, A1N1W7
Canada, Ontario

Toronto, Ontario, Canada, M9W4L6

Newmarket, Ontario, Canada, L3Y7V1

Sudbury, Ontario, Canada, P3E1H5

Sarnia, Ontario, Canada, N7T4X3

Toronto, Ontario, Canada, M9V4B4

Newmarket, Ontario, Canada, L3Y5G8
Canada, Quebec

Montreal, Quebec, Canada, H1S3A9

Montreal, Quebec, Canada, H4N2W2

Drummondville, Quebec, Canada, J2B7T1

Gatineau, Quebec, Canada, J9A1K7

Trois-Rivieres, Quebec, Canada, G8T7A1

Granby, Quebec, Canada, J2G8Z9

Sherbrooke, Quebec, Canada, J1H1Z1

Pointe-Claire, Quebec, Canada, H9R4S3

Mirabel, Quebec, Canada, J7J2K8

Cowansville, Quebec, Canada, J2K2X9

Sponsors and Collaborators

Labopharm Inc.

More Information

No publications provided

Responsible Party:	Labopharm Inc. ( Sybil Robertson, Vice-President Regulatory Affairs )
Study ID Numbers:	06CCL3-001
Study First Received:	March 20, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00643383 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Tramadol
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Low Back Pain
Narcotics
Pain
Back Pain
Pharmacologic Actions
Signs and Symptoms

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Acetaminophen

ClinicalTrials.gov processed this record on November 22, 2009