Clinical trial NCT00397683: A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Call for Information
state: California
city: Pomona
country: United States
facility: Call for Information
state: California
city: Torrance
country: United States
facility: Call for Information
state: California
city: Upland
country: United States
facility: Call for Information
state: California
city: Coral Gables
country: United States
facility: Call for Information
state: Florida
city: Hialeah
country: United States
facility: Call for Information
state: Florida
city: South Miami
country: United States
facility: Call for Information
state: Florida
city: Rochester
country: United States
facility: Call for Information
state: New York
city: Rochester
country: United States
facility: Call for Information
state: New York
city: Rochester
country: United States
facility: Call for Information
state: New York
city: Norristown
country: United States
facility: Call for Information
state: Pennsylvania
city: Perkasie
country: United States
facility: Call for Information
state: Pennsylvania
city: Santiago
country: Chile
facility: Merck Sharp & Dohme (I.A.) Corp.
city: Bogota
country: Colombia
facility: Frosst Laboratories Inc.
state: Cundinamarca
city: Mexico
country: Mexico
facility: Merck Sharp & Dohme De Mexico, S.A. De C.V.
state: D.f.
city: Warszawa
country: Poland
facility: MSD Polska Sp. z o.o. Dzial Medyczny
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: