Effect of Etoricoxib to Treat Chronic Low Back Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00393354

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Etoricoxib

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Etoricoxib
Cyclooxygenase Inhibitors
Low Back Pain
Pain
Back Pain
Recurrence

Signs and Symptoms
Analgesics, Non-Narcotic
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Etoricoxib
Cyclooxygenase Inhibitors
Low Back Pain
Pain
Enzyme Inhibitors
Back Pain
Pharmacologic Actions

Signs and Symptoms
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2009