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

Osteoarthritis Clinical Trial

Official title:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

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

• Osteoarthritis

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