A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00296569

Enrollment

150

Registered

2006-02-27

Start date

2005-09-30

Completion date

2006-05-31

Last updated

2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGMK0686

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety and tolerability over a 4-week treatment period	over a 4-week treatment period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026