NCT00092365

Brief Summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_3

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

April 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

September 22, 2004

Last Update Submit

May 5, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.

Secondary Outcomes (2)

  • OA of the knee as measured by PGART over 6 wks of treatment.

  • WOMAC Question #1 over 6 wks of treatment.

Interventions

MK0966, rofecoxibDRUG
Comparator: celecoxib, placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Osteoarthritis of the knee which requires treatment with medication for pain relief

You may not qualify if:

  • Any known allergy to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Birbara C, Ruoff G, Sheldon E, Valenzuela C, Rodgers A, Petruschke RA, Chang DJ, Tershakovec AM. Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies. Curr Med Res Opin. 2006 Jan;22(1):199-210. doi: 10.1185/030079906X80242.

    PMID: 16393445BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2004

First Posted

September 27, 2004

Study Start

April 1, 2003

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

May 9, 2017

Record last verified: 2017-05