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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00397683
Other study ID # 0822-011
Secondary ID 2006_517
Status Terminated
Phase Phase 2
First received November 8, 2006
Last updated October 30, 2015
Start date October 2006
Est. completion date April 2007

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MK0822


Locations

Country Name City State
Chile Merck Sharp & Dohme (I.A.) Corp. Santiago
Colombia Frosst Laboratories Inc. Bogota Cundinamarca
Mexico Merck Sharp & Dohme De Mexico, S.A. De C.V. Mexico D.f.
Poland MSD Polska Sp. z o.o. Dzial Medyczny Warszawa
United States Call for Information Coral Gables Florida
United States Call for Information Hialeah Florida
United States Call for Information Norristown Pennsylvania
United States Call for Information Palm Desert California
United States Call for Information Perkasie Pennsylvania
United States Call for Information Pomona California
United States Call for Information Rochester New York
United States Call for Information Rochester New York
United States Call for Information Rochester New York
United States Call for Information South Miami Florida
United States Call for Information Torrance California
United States Call for Information Upland California

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Chile,  Colombia,  Mexico,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Proprietary Information - Exploratory (Non-Confirmatory) Trial
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