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Clinical Trials/NCT00296569
NCT00296569
Completed
Phase 2

A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip

Merck Sharp & Dohme LLC0 sites150 target enrollmentSeptember 2005
ConditionsOsteoarthritis
DrugsMK0686

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Merck Sharp & Dohme LLC
Enrollment
150
Primary Endpoint
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
May 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases
  • Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment
  • Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA
  • females must be either post-menopausal or surgically sterilized

Exclusion Criteria

  • No history of concurrent arthritic disease
  • No history of neoplastic disease within a specified duration
  • No history of disease that causes malabsorption
  • Chronic use of certain medications excluded

Outcomes

Primary Outcomes

Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.

Time Frame: over 4 weeks of treatment

Secondary Outcomes

  • Safety and tolerability over a 4-week treatment period(over a 4-week treatment period)

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