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 - Tabular View

Tracking Information
First Received Date ^ICMJE	March 20, 2008
Last Updated Date	April 2, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Pain Intensity change from Baseline
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00643383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Overall satisfaction with the study medication Safety evaluation
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Parallel Assignment
Condition ^ICMJE	Acute Low Back Pain
Intervention ^ICMJE	Drug: Combination drug (Acetaminophen + Tramadol) Drug: Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	250
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00643383
Responsible Party	Sybil Robertson, Vice-President Regulatory Affairs, Labopharm Inc.
Study ID Numbers ^ICMJE	06CCL3-001
Study Sponsor ^ICMJE	Labopharm Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Labopharm Inc.
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP