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A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain

Primary Purpose

Back Pain, Low Back Pain

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tramadol hydrochloride , acetaminophen
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 Back Pain focused on measuring Pain, Acute Low Back Pain, Back, Lower back

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Symptomatic with acute low back pain, with or without radiating pain no lower than the knee, for 2 to 10 days Average acute low back pain score in the last 24 hours of >= 5 on an 11-point scale at Visit 1 In generally good health If female of childbearing potential, using an acceptable method of birth control Exclusion Criteria: No use of ibuprofen, acetaminophen, or aspirin within 6 hours of the first dose of study medication No use of any other prescription or over-the-counter medication for pain within 24 hours of the first dose of study medication No use of medications for epilepsy or depression in the past 3 weeks No use of steroids within 3 months of study entry or any other long-term treatment with steroids No use of of tramadol HCl, tramadol HCl/acetaminophen, or any other oral opioid or opioid combination during the course of the current episode of acute low back pain No use of transcutaneous electrical nerve stimulation (TENS) unit within 2 weeks of study entry No use of an investigational drug in past 30 days No use of botulinum toxin for the treatment of back pain within 3 months No chronic continuous back pain or acute pain on top of chronic back pain No acute low back pain associated with chills or fever No pain below the knee No neurological signs, such as muscle weakness No risk of spinal infection No worsening of pain when lying down No history of significant medical conditions No need for urgent evaluation of the spine by neuroimaging No treatment during this episode by a chiropractor, physical therapy, massage, acupuncture, or Reiki treatments No current litigation over back pain No back pain related to a motor vehicle accident or work injury No pain more painful than their low back pain No progressive or degenerative neurological disorders No kidney damage Not pregnant or breast-feeding No condition that might affect the way the body absorbs or processes the study drug No bleeding condition No history of suicidal ideas or suicide attempts in the past 2 years No history of a major psychiatric disorder in past 6 months No history of drug or alcohol abuse or dependence

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pain relief on Day 2 of treatment with study medication

    Secondary Outcome Measures

    Analgesic scores for the entire treatment period including: pain relief across all study days, Brief Pain Inventory, Roland and Morris Disability Questionnaire, Subject Global Impression of Change at final visit

    Full Information

    First Posted
    September 13, 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
    NCT00210561
    Brief Title
    A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) for the Treatment of Acute Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study was stopped shortly after initiation due to change in strategic direction of the company; no safety concerns were observed that impacted this decision.
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (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

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/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 has been shown to be effective for the treatment of acute musculoskeletal pain. The current study is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients with acute low back pain for 2 to 10 days before study entry will be enrolled. At the screening visit, patients will complete questionnaires about their level of pain and disability. Patients will be randomized (like the toss of a coin) to receive either tramadol HCl/acetaminophen or placebo. Patients will take 2 tablets of study medication every 4 to 6 hours as needed for low back pain, but not more than 8 tablets per 24-hour period. Patients will call the Interactive Voice Response (IVR) system to complete a pain assessment prior to taking the first dose of study medication. Also starting on Day 1, patients will call the IVR system every night at bedtime for the remainder of the study, to complete assessments related to the following: low back pain and pain relief in the last 24 hours, current pain, pain interference with sleep and the number of study medication tablets and doses taken that day. The objective of this study is to compare the effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of acute low back pain. 2 tramadol/acetaminophen 37.5/325 milligram oral tablets or 2 placebo tablets every 4 to 6 hours as needed for low back pain, but no more than 8 tablets per day, for 5 days, or until there is no further need for pain medication

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain, Low Back Pain
    Keywords
    Pain, Acute Low Back Pain, Back, Lower back

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    tramadol hydrochloride , acetaminophen
    Primary Outcome Measure Information:
    Title
    Pain relief on Day 2 of treatment with study medication
    Secondary Outcome Measure Information:
    Title
    Analgesic scores for the entire treatment period including: pain relief across all study days, Brief Pain Inventory, Roland and Morris Disability Questionnaire, Subject Global Impression of Change at final visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic with acute low back pain, with or without radiating pain no lower than the knee, for 2 to 10 days Average acute low back pain score in the last 24 hours of >= 5 on an 11-point scale at Visit 1 In generally good health If female of childbearing potential, using an acceptable method of birth control Exclusion Criteria: No use of ibuprofen, acetaminophen, or aspirin within 6 hours of the first dose of study medication No use of any other prescription or over-the-counter medication for pain within 24 hours of the first dose of study medication No use of medications for epilepsy or depression in the past 3 weeks No use of steroids within 3 months of study entry or any other long-term treatment with steroids No use of of tramadol HCl, tramadol HCl/acetaminophen, or any other oral opioid or opioid combination during the course of the current episode of acute low back pain No use of transcutaneous electrical nerve stimulation (TENS) unit within 2 weeks of study entry No use of an investigational drug in past 30 days No use of botulinum toxin for the treatment of back pain within 3 months No chronic continuous back pain or acute pain on top of chronic back pain No acute low back pain associated with chills or fever No pain below the knee No neurological signs, such as muscle weakness No risk of spinal infection No worsening of pain when lying down No history of significant medical conditions No need for urgent evaluation of the spine by neuroimaging No treatment during this episode by a chiropractor, physical therapy, massage, acupuncture, or Reiki treatments No current litigation over back pain No back pain related to a motor vehicle accident or work injury No pain more painful than their low back pain No progressive or degenerative neurological disorders No kidney damage Not pregnant or breast-feeding No condition that might affect the way the body absorbs or processes the study drug No bleeding condition No history of suicidal ideas or suicide attempts in the past 2 years No history of a major psychiatric disorder in past 6 months No history of drug or alcohol abuse or dependence
    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

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=495&filename=CR002863_CSR.pdf
    Description
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) for the Treatment of Acute Low Back Pain

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