Status:
COMPLETED
A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Sprains and Strains
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients w...
Detailed Description
Tramadol HCl/acetaminophen is approved for short-term (five days or less) management of acute pain. The combination of tramadol HCl/acetaminophen provides a more rapid onset of action compared with tr...
Eligibility Criteria
Inclusion
- Diagnosis of acute ankle sprain with a partial ligament tear within 48 hours of study entry
- At least moderate pain from the ankle sprain at baseline and before first dose of study medication
- In generally good health
- If female of childbearing potential, using acceptable method of birth control
Exclusion
- Use of ibuprofen within 6 hours or topical pain relievers within 12 hours of study entry
- Use of tramadol HCl, tramadol HCl/acetaminophen, or hydrocodone bitartrate/acetaminophen within 30 days of study entry
- Use of epilepsy or antidepressant medications 3 weeks before the study entry
- Chronic use of pain medications or muscle relaxants for any reason during the study
- No use of steroid medications (oral or inhaled) on a chronic basis
- Required hospitalization to treat the ankle sprain
- Head trauma
- Pain greater than the pain caused by the ankle sprain
- Complete ligament tear
- Bone fractures on x-ray
- Required physical therapy, other than for crutch training
- History of kidney damage
- Pregnant or breast-feeding patients
- Condition that might affect the way the body absorbs or processes the study medication
- Major psychiatric disorder, history of attempted suicides/suicidal tendencies
- History of substance abuse or chronic alcohol abuse in the past 6 months
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT00236535
Start Date
December 1 2003
End Date
October 1 2004
Last Update
June 10 2011
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