Acute Low Back Pain
Conditions
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.
Interventions
DRUGCombination drug (Acetaminophen + Tramadol)
DRUGPlacebo
Sponsors
Labopharm Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity change from Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall satisfaction with the study medication | — |
| Safety evaluation | — |
Countries
Canada, United States
Outcome results
None listed