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

NCT ID: NCT00397683

Last Updated: 2015-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MK0822

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Call for Information

Palm Desert, California, United States

Site Status

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Pomona, California, United States

Site Status

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Torrance, California, United States

Site Status

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Upland, California, United States

Site Status

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Coral Gables, Florida, United States

Site Status

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Hialeah, Florida, United States

Site Status

Call for Information

South Miami, Florida, United States

Site Status

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Rochester, New York, United States

Site Status

Call for Information

Rochester, New York, United States

Site Status

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Rochester, New York, United States

Site Status

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Norristown, Pennsylvania, United States

Site Status

Call for Information

Perkasie, Pennsylvania, United States

Site Status

Merck Sharp & Dohme (I.A.) Corp.

Santiago, , Chile

Site Status

Frosst Laboratories Inc.

Bogota, Cundinamarca, Colombia

Site Status

Merck Sharp & Dohme De Mexico, S.A. De C.V.

México, D.f., Mexico

Site Status

MSD Polska Sp. z o.o. Dzial Medyczny

Warsaw, , Poland

Site Status

Countries

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United States Chile Colombia Mexico Poland

Other Identifiers

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2006_517

Identifier Type: -

Identifier Source: secondary_id

0822-011

Identifier Type: -

Identifier Source: org_study_id

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