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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 24, 2006
Last updated: December 23, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Osteoarthritis Drug: MK0686 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Safety and tolerability over a 4-week treatment period [ Time Frame: over a 4-week treatment period ]

Enrollment: 150
Study Start Date: September 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00296569

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00296569     History of Changes
Other Study ID Numbers: 0686-006
Study First Received: February 24, 2006
Last Updated: December 23, 2014

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 21, 2017