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

NCT00236535 | Completed Phase 3

• 1 other identifier: CR002815
• Study Type: interventional
• Target: 603
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Sprains and Strains; Pain

Keywords

musculoskeletal; Pain; sprained ankle; ligament; sprain; ankle

Outcome Measures

Primary Outcomes (1)

• Total pain relief (TOTPAR) over 4 hours on Day 1 after the administration of the first dose of study medication

Secondary Outcomes (1)

• Sum of Pain Intensity Differences; Sum of Pain Relief Intensity Differences; Pain Visual Analog Scores; mean daily pain intensity and relief; final pain intensity, relief and activity impairment assessment; subject overall medication assessment

Interventions

tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Publications (1)

• Hewitt DJ, Todd KH, Xiang J, Jordan DM, Rosenthal NR; CAPSS-216 Study Investigators. Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. Ann Emerg Med. 2007 Apr;49(4):468-80, 480.e1-2. doi: 10.1016/j.annemergmed.2006.08.030. Epub 2006 Nov 20.

  PMID: 17113683 RESULT

Related Links

• A Comparison of the Efficacy and Safety of Tramadol HCl / Acetaminophen Versus Hydrocodone Bitartrate / Acetaminophen Versus Placebo in Subjects with Acute Musculoskeletal Pain

MeSH Terms

Conditions

Sprains and Strains; Pain; Ankle Injuries

Interventions

Tramadol; Acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: December 1, 2003
• Study Completion: October 1, 2004
• Last Updated: June 10, 2011

Record last verified: 2010-04