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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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 who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Acetaminophen; Hydrocodone; Tramadol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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