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

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ClinicalTrials.gov Identifier: NCT00210561
Recruitment Status : Terminated (Study was stopped shortly after initiation due to change in strategic direction of the company; no safety concerns were observed that impacted this decision.)
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Pain relief on Day 2 of treatment with study medication
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00210561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Low Back Pain
Intervention  ICMJE Drug: tramadol hydrochloride , acetaminophen
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 21, 2009)
22
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
400
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00210561
Other Study ID Numbers  ICMJE CR002863
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP