Skip to main content
OpenTrials
Completed

NCT Number: NCT00296569

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0686

Drug

Primary outcomes

  1. 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

  1. Safety and tolerability over a 4-week treatment period

    Time frame: over a 4-week treatment period

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 27, 2006
Registry last updated
Dec 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.