NCT00140920

Brief Summary

A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started May 2004

Shorter than P25 for phase_4 pain

Status
terminated

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

May 25, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

August 30, 2005

Last Update Submit

May 5, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • Quantity of patient controlled

  • Post-operative morphine administration

Interventions

MK0966; rofecoxibDRUG
Comparator: diclofenac 2x 75 mgDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

May 25, 2004

Primary Completion

September 27, 2004

Study Completion

September 27, 2004

Last Updated

May 9, 2017

Record last verified: 2017-05