A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)

October 30, 2015 updated by: Merck Sharp & Dohme LLC

Proprietary Information - Exploratory (Non-Confirmatory) Trial

The purpose of this study is to test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 6761641
        • Merck Sharp & Dohme (I.A.) Corp.
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Frosst Laboratories Inc.
  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 1090
        • Merck Sharp & Dohme De Mexico, S.A. De C.V.
  • Poland
      • Warszawa, Poland, 00-867
        • MSD Polska Sp. z o.o. Dzial Medyczny
  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Call For Information
      • Pomona, California, United States, 91767
        • Call For Information
      • Torrance, California, United States, 90505
        • Call For Information
      • Upland, California, United States, 91786
        • Call For Information
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Call For Information
      • Hialeah, Florida, United States, 33010
        • Call For Information
      • South Miami, Florida, United States, 33143-0000
        • Call For Information
    • New York
      • Rochester, New York, United States, 14168
        • Call For Information
      • Rochester, New York, United States, 14609
        • Call For Information
      • Rochester, New York, United States, 14618
        • Call For Information
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Call For Information
      • Perkasie, Pennsylvania, United States, 18944
        • Call For Information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
  • Patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
  • Specific radiographic (X-ray) and MRI features must also be satisfied

Exclusion Criteria:

  • Non-osteoarthritic causes of knee pain
  • Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons
  • Previous septic arthritis, tibial osteotomy or knee replacement in both knees
  • Acute injury of knee ligaments or meniscus in past 2 years
  • Knee arthroscopy in past 12 months
  • Anticipated arthroscopy or surgery in next 18 months
  • Use of intra-articular injections of hyaluronan (e.g. Hyalgan (TM), Synvisc (TM), Orthovisc (TM)) in past 6 months, or injections of glucocorticoids (e.g. Kenalog (TM), Aristospan (TM), Depo-Medrol (TM)) in past 3 months or anticipated knee injections during the study
  • Glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study
  • Other exclusion criteria apply-Please ask the study doctor for details

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures

Outcome Measure
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria

November 8, 2006

First Posted (Estimate)

November 9, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0822-011
  • 2006_517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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