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

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Sep 13, 2005

Keywords

ClinConnect Summary

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 tra...

Gender

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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