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

Trial end date:
Target enrollment:
Participant gender:
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 4
Accepts Healthy Volunteers?
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
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