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

Phase 2

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT00397683
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-09
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures

Name	Time	Method
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Trial Locations

Locations (5)

Merck Sharp & Dohme De Mexico, S.A. De C.V.; 🇲🇽 Mexico, D.f., Mexico

Call for Information; 🇺🇸 Perkasie, Pennsylvania, United States

MSD Polska Sp. z o.o. Dzial Medyczny; 🇵🇱 Warszawa, Poland

Frosst Laboratories Inc.; 🇨🇴 Bogota, Cundinamarca, Colombia

Merck Sharp & Dohme (I.A.) Corp.; 🇨🇱 Santiago, Chile