Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00242489
First received: October 18, 2005
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis
Drug: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)
Drug: Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)

Secondary Outcome Measures:
  • Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy

Estimated Enrollment: 550
Study Start Date: June 1998
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
  • Positive therapeutic effect from prior NSAID therapy.
  • Worsening of symptoms upon withdrawal of prior treatment.
  • With the exception of OA, in otherwise good health

Exclusion Criteria:

  • Weight no more than 280 pounds (male or female).
  • Recent, sustained use of gastroprotective agents.
  • History of arthroscopy of the affected knee within 6 months prior to study entry.
  • History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242489

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

Publications:
ClinicalTrials.gov Identifier: NCT00242489     History of Changes
Other Study ID Numbers: 2005_088
Study First Received: October 18, 2005
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Arcoxia

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014