Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00090181

First received: August 25, 2004

Last updated: November 6, 2014

Last verified: November 2014

History of Changes

Purpose

The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.

Condition	Intervention	Phase
Chronic Low Back Pain	Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks Drug: Comparator: diclofenac / Duration of Treatment: 4 weeks	Phase 4


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, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Diclofenac

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Lower back pain intensity
Safety and tolerability

Secondary Outcome Measures:

Disability questionnaire
Patient global assessment of response to therapy


Enrollment:	401
Study Start Date:	June 2004
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
Patients should have at least 3 months of Low Back Pain.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090181

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00090181 History of Changes
Other Study ID Numbers:	0663-806, 2004_003
Study First Received:	August 25, 2004
Last Updated:	November 6, 2014
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:


Arcoxia

Additional relevant MeSH terms:


Back Pain Low Back Pain Nervous System Diseases	Neurologic Manifestations Pain Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015

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