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

• Status: Terminated
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Acetaminophen; Tramadol

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