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

This study has been completed.

First Received on March 20, 2008. Last Updated on January 12, 2010 History of Changes

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:	Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Tramadol 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
Study Completion Date:	February 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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

Show 38 Study Locations

Sponsors and Collaborators

Labopharm Inc.

More Information

No publications provided

Responsible Party:	Sybil Robertson, Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00643383 History of Changes
Other Study ID Numbers:	06CCL3-001
Study First Received:	March 20, 2008
Last Updated:	January 12, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 12, 2012