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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

Primary Purpose

Sprains and Strains, Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprains and Strains focused on measuring musculoskeletal, Pain, sprained ankle, ligament, sprain, ankle

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236535
    Brief Title
    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
    Official Title
    A Comparison of the Efficacy and Safety of Tramadol HCl/Acetaminophen Versus Hydrocodone Bitartrate/Acetaminophen Versus Placebo in Subjects With Acute Musculoskeletal Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.

    4. Oversight

    5. Study Description

    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.
    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 tramadol HCl alone and a longer duration of action than acetaminophen alone. Therefore, the combination of tramadol HCl/acetaminophen may be effective for the treatment of acute musculoskeletal pain. The current study is a multicenter, randomized, double-blind, inpatient/outpatient, active-controlled, placebo-controlled, parallel-group study. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription medication will be enrolled. Patients will be randomized to receive either oral tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo. Patients will receive 2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo. Patient may take 1 or 2 capsules up to 4 times daily as needed but no more than 8 capsules per day for 5 daysThe first dose of study medication will be given at the study site. Patients will complete a Pain Visual Analog Scale, Pain Relief Rating Scale and Pain Intensity Scale at 1, 2, 3 and 4 hours after the first dose of study medication. On Day 1, after the 4-hour evaluations, patients will be dispensed study medication for use throughout the rest of the study. Patients will also evaluate and record in a daily diary the pain intensity ratings and pain relief scores for Days 1-5 of the double-blind phase. At the final visit, patients will complete a Pain Intensity Scale and Pain Relief Rating Scale, an Activity Impairment Assessment and a Subject Overall Medication Assessment. At the first dose, patients are dispensed 2 capsules of study medication. Thereafter, patients may take 1 or 2 capsules of study medication orally up to 4 times per day, as needed for pain, but no more than 8 capsules per day. The objective of this study is to compare the pain-relieving effectiveness and safety of tramadol HCl/acetaminophen versus hydrocodone bitartrate/acetaminophen versus placebo for the treatment of acute musculoskeletal pain from an ankle sprain with a partial ligament tear. 2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo; patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8 capsules per day for 5 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sprains and Strains, Pain
    Keywords
    musculoskeletal, Pain, sprained ankle, ligament, sprain, ankle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    603 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo
    Primary Outcome Measure Information:
    Title
    Total pain relief (TOTPAR) over 4 hours on Day 1 after the administration of the first dose of study medication
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17113683
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=491&filename=CR002815_CSR.pdf
    Description
    A Comparison of the Efficacy and Safety of Tramadol HCl / Acetaminophen Versus Hydrocodone Bitartrate / Acetaminophen Versus Placebo in Subjects with Acute Musculoskeletal Pain

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    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

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