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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00296569
First received: February 24, 2006
Last updated: April 24, 2008
Last verified: April 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability over a 4-week treatment period [ Time Frame: over a 4-week treatment period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296569

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00296569     History of Changes
Other Study ID Numbers: 2006_011, MK0686-006
Study First Received: February 24, 2006
Last Updated: April 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014