NCT00397683

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
5 countries

16 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

November 8, 2006

Last Update Submit

October 30, 2015

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Interventions

MK0822DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Call for Information

Palm Desert, California, 92260, United States

Location

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Pomona, California, 91767, United States

Location

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Torrance, California, 90505, United States

Location

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Upland, California, 91786, United States

Location

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Coral Gables, Florida, 33134, United States

Location

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Hialeah, Florida, 33010, United States

Location

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South Miami, Florida, 33143-0000, United States

Location

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Rochester, New York, 14168, United States

Location

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Rochester, New York, 14609, United States

Location

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Rochester, New York, 14618, United States

Location

Call for Information

Norristown, Pennsylvania, 19401, United States

Location

Call for Information

Perkasie, Pennsylvania, 18944, United States

Location

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

Santiago, 6761641, Chile

Location

Frosst Laboratories Inc.

Bogota, Cundinamarca, Colombia

Location

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

México, D.f., 1090, Mexico

Location

MSD Polska Sp. z o.o. Dzial Medyczny

Warsaw, 00-867, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

odanacatib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

ME(1)CO(1)CL(1)US(12)PL(1)