Effect of Etoricoxib to Treat Chronic Low Back Pain

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00393354

First received: October 26, 2006

Last updated: May 7, 2009

Last verified: May 2009

History of Changes

Purpose

Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

Condition	Intervention	Phase
Recurrent Low Back Pain	Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Secondary Outcome Measures:

Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

Estimated Enrollment:	300
Study Start Date:	April 2000

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Low back pain for previous 3 months and majority of days in last month
Regular use of acetaminophen or NSAID to treat low back pain in past month
Judged to be in otherwise good health

Exclusion Criteria:

Low back pain that is due to secondary causes
Radicular/myelopathic pain
Surgery for low back pain within the past 6 months
Active lawsuit or claim pertaining to their low back pain
Disease that may confound the results of the study or pose risk to the patients
Corticosteroid use in past month
Previous participation in MK0663 study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393354

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66.

Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83.

Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine. 2008 Mar 1;33(5):533-8.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00393354 History of Changes
Other Study ID Numbers:	2006_548, MK0663-041
Study First Received:	October 26, 2006
Last Updated:	May 7, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013

To Top