Back to resultsA 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
Primary Purpose
Acute Low Back Pain
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Combination drug (Acetaminophen + Tramadol)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Low Back Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pain Intensity change from Baseline
Secondary Outcome Measures
Overall satisfaction with the study medication
Safety evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643383
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labopharm Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Combination drug (Acetaminophen + Tramadol)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain Intensity change from Baseline
Secondary Outcome Measure Information:
Title
Overall satisfaction with the study medication
Title
Safety evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
Country
United States
City
Bryan
State/Province
Texas
ZIP/Postal Code
77082
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A4X7
Country
Canada
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N1W7
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y5G8
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y7V1
Country
Canada
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T4X3
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E1H5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V4B4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W4L6
Country
Canada
City
Cowansville
State/Province
Quebec
ZIP/Postal Code
J2K2X9
Country
Canada
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B7T1
Country
Canada
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J9A1K7
Country
Canada
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G8Z9
Country
Canada
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J2K8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1S3A9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N2W2
Country
Canada
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R4S3
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H1Z1
Country
Canada
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T7A1
Country
Canada
City
Quebec
ZIP/Postal Code
G1G4A2
Country
Canada
City
Quebec
ZIP/Postal Code
G1V4X7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22458917
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.
Results Reference
derived
Learn more about this trial
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
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