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

NCT00210561 | Terminated Phase 4

• 1 other identifier: CR002863
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain; Low Back Pain

Keywords

Pain; Acute Low Back Pain; Back; Lower back

Outcome Measures

Primary Outcomes (1)

• Pain relief on Day 2 of treatment with study medication

Secondary Outcomes (1)

• 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

Interventions

tramadol hydrochloride , acetaminophen DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Links

• 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

MeSH Terms

Conditions

Back Pain; Low Back Pain; Pain

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 10, 2011

Record last verified: 2010-04