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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: MK0686

Study type: Interventional

Funder types: Industry

Identifiers

NCT00296569

2006_011

MK0686-006

0686-006

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind