Study of MK0663 in Patients With Chronic Low Back Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090181

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 IV

MedlinePlus related topics: Back Pain

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Etoricoxib

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

Lower back pain intensity
Safety and tolerability

Secondary Outcome Measures:

Disability questionnaire
Patient global assessment of response to therapy

Estimated Enrollment:	400
Study Start Date:	June 2004

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

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

Locations

United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; The 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.

Study ID Numbers:	2004_003
Study First Received:	August 25, 2004
Last Updated:	September 5, 2006
ClinicalTrials.gov Identifier:	NCT00090181 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck:

Arcoxia

Study placed in the following topic categories:

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

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
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Etoricoxib
Low Back Pain
Diclofenac
Enzyme Inhibitors
Pain
Back Pain

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

ClinicalTrials.gov processed this record on May 06, 2009