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
2 other identifiers
interventional
277
2 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2008
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMay 1, 2012
April 1, 2012
10 months
March 20, 2008
April 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Intensity change from Baseline
Secondary Outcomes (2)
Overall satisfaction with the study medication
Safety evaluation
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Labopharm Inc.lead
Study Sites (38)
Unknown Facility
Montgomery, Alabama, 36117, United States
Unknown Facility
Centennial, Colorado, 80112, United States
Unknown Facility
Hialeah, Florida, 33013, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
New Port Richey, Florida, 34652, United States
Unknown Facility
Indianapolis, Indiana, 46254, United States
Unknown Facility
Waterloo, Iowa, 50702, United States
Unknown Facility
Baton Rouge, Louisiana, 70809, United States
Unknown Facility
Brockton, Massachusetts, 02301, United States
Unknown Facility
Minneapolis, Minnesota, 55415, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Rapid City, South Dakota, 57702, United States
Unknown Facility
Crossville, Tennessee, 38555, United States
Unknown Facility
Bryan, Texas, 77082, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Bathurst, New Brunswick, E2A4X7, Canada
Unknown Facility
Mount Pearl, Newfoundland and Labrador, A1N1W7, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E1H5, Canada
Unknown Facility
Newmarket, Ontario, L3Y5G8, Canada
Unknown Facility
Newmarket, Ontario, L3Y7V1, Canada
Unknown Facility
Sarnia, Ontario, N7T4X3, Canada
Unknown Facility
Toronto, Ontario, M9V4B4, Canada
Unknown Facility
Toronto, Ontario, M9W4L6, Canada
Unknown Facility
Cowansville, Quebec, J2K2X9, Canada
Unknown Facility
Drummondville, Quebec, J2B7T1, Canada
Unknown Facility
Gatineau, Quebec, J9A1K7, Canada
Unknown Facility
Granby, Quebec, J2G8Z9, Canada
Unknown Facility
Mirabel, Quebec, J7J2K8, Canada
Unknown Facility
Montreal, Quebec, H1S3A9, Canada
Unknown Facility
Montreal, Quebec, H4N2W2, Canada
Unknown Facility
Pointe-Claire, Quebec, H9R4S3, Canada
Unknown Facility
Québec, Quebec, G1G4A2, Canada
Unknown Facility
Québec, Quebec, G1V4X7, Canada
Unknown Facility
Sherbrooke, Quebec, J1H1Z1, Canada
Unknown Facility
Trois-Rivières, Quebec, G8T7A1, Canada
Related Publications (1)
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.
PMID: 22458917DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
March 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
May 1, 2012
Record last verified: 2012-04