Status:
TERMINATED
A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Back Pain
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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/acetaminop...
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00210561
Start Date
March 1 2005
End Date
April 1 2005
Last Update
June 10 2011
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