Status:

COMPLETED

A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Osteoarthritis

Eligibility:

All Genders

40-65 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2006

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00296569

Start Date

September 1 2005

End Date

May 1 2006

Last Update

December 24 2014

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