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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 25, 2004
Last updated: November 27, 2015
Last verified: November 2015
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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00090181

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00090181     History of Changes
Other Study ID Numbers: 0663-806  2004_003 
Study First Received: August 25, 2004
Last Updated: November 27, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors processed this record on October 21, 2016