A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00397683

Purpose

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).

Condition	Intervention	Phase
Osteoarthritis	Drug: MK0822	Phase II

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Proprietary Information - Exploratory (Non-Confirmatory) Trial

Further study details as provided by Merck:

Primary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Study Start Date:

November 2006

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397683

Locations

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2006_517
Study First Received:	November 8, 2006
Last Updated:	April 6, 2007
ClinicalTrials.gov Identifier:	NCT00397683
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009