NCT00092378

Brief Summary

This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for phase_3 postoperative-pain

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3 postoperative-pain

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, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
10 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

3 months

First QC Date

September 22, 2004

Last Update Submit

May 5, 2017

Conditions

Postoperative Pain

Keywords

Bunionectomy

Outcome Measures

Primary Outcomes (1)

  • Overall analgesic effect over 8 hours

Secondary Outcomes (5)

  • Time to onset of analgesic effect.

  • The use of supplemental analgesia on Days 2-3.

  • Peak analgesic effect on Day 1.

  • Overall safety and tolerability.

  • The analgesic effect on Days 2-3.

Interventions

MK0966, rofecoxibDRUG
Comparator: diclofenac sodium, placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Bunion removal

You may not qualify if:

  • Any known allergies to the study design

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.

    PMID: 15462686BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

September 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

May 9, 2017

Record last verified: 2017-05