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: March 20, 2008 Last Updated: April 2, 2009 History of Changes

Sponsored by:	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

Show 37 Study Locations

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

Study placed in the following topic categories:

Tramadol
Low Back Pain
Central Nervous System Depressants
Pain
Narcotics
Back Pain
Signs and Symptoms

Analgesics, Non-Narcotic
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Acetaminophen
Analgesics, Opioid

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 July 02, 2009