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

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210561

Purpose

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.

Condition	Intervention	Phase
Back Pain Low Back Pain	Drug: tramadol hydrochloride , acetaminophen	Phase IV

MedlinePlus related topics: Back Pain

Drug Information available for: Tramadol hydrochloride Tramadol Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Pain relief on Day 2 of treatment with study medication

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	March 2005
Study Completion Date:	April 2005

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 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 tramadol HCl/acetaminophen or placebo. Patients will take 2 tablets of study medication every 4 to 6 hours as needed for low back pain, but not more than 8 tablets per 24-hour period. Patients will call the Interactive Voice Response (IVR) system to complete a pain assessment prior to taking the first dose of study medication. Also starting on Day 1, patients will call the IVR system every night at bedtime for the remainder of the study, to complete assessments related to the following: low back pain and pain relief in the last 24 hours, current pain, pain interference with sleep and the number of study medication tablets and doses taken that day. The objective of this study is to compare the effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of acute low back pain.

2 tramadol/acetaminophen 37.5/325 milligram oral tablets or 2 placebo tablets every 4 to 6 hours as needed for low back pain, but no more than 8 tablets per day, for 5 days, or until there is no further need for pain medication

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210561

Sponsors and Collaborators

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

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Study Director:

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

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

More Information

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR002863
Study First Received:	September 13, 2005
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00210561
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Lower back
Back
Pain
Acute Low Back Pain

Study placed in the following topic categories:

Signs and Symptoms
Tramadol
Neurologic Manifestations
Low Back Pain

Pain
Back Pain
Acetaminophen

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009