NCT00296569

Brief Summary

This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

February 24, 2006

Last Update Submit

December 23, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.

    over 4 weeks of treatment

Secondary Outcomes (1)

  • Safety and tolerability over a 4-week treatment period

    over a 4-week treatment period

Interventions

MK0686DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases
  • Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment
  • Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA
  • females must be either post-menopausal or surgically sterilized

You may not qualify if:

  • No history of concurrent arthritic disease
  • No history of neoplastic disease within a specified duration
  • No history of disease that causes malabsorption
  • Chronic use of certain medications excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

methyl 3-chloro-3'-fluoro-4'-(1-(((1-((trifluoroacetyl)amino)cyclopropyl)carbonyl)amino)ethyl)-1,1'-biphenyl-2-carboxylate

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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

September 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

December 24, 2014

Record last verified: 2014-12