Clinical trial NCT00643383: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Low Back Pain
Lead sponsor: Labopharm Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pain Intensity change from Baseline
Secondary outcomes:
measure: Overall satisfaction with the study medication
measure: Safety evaluation
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Centennial
country: United States
state: Colorado
city: Hialeah
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Baton Rouge
country: United States
state: Louisiana
city: Brockton
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Oklahoma City
country: United States
state: Oklahoma
city: Rapid City
country: United States
state: South Dakota
city: Crossville
country: United States
state: Tennessee
city: Bryan
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Bathurst
country: Canada
state: New Brunswick
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: Newmarket
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Cowansville
country: Canada
state: Quebec
city: Drummondville
country: Canada
state: Quebec
city: Gatineau
country: Canada
state: Quebec
city: Granby
country: Canada
state: Quebec
city: Mirabel
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Quebec
country: Canada
Study officials:
References:
citation: Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, Robertson S. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Curr Med Res Opin. 2012 May;28(5):847-57. doi: 10.1185/03007995.2012.681035. Epub 2012 Apr 25.