A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092378

Enrollment

251

Registered

2004-09-27

Start date

2003-09-01

Completion date

2003-12-01

Last updated

2017-05-09

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

Conditions

Postoperative Pain

Keywords

Bunionectomy

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.

Detailed description

The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Interventions

DRUGMK0966, rofecoxib

DRUGComparator: diclofenac sodium, placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Bunion removal

Exclusion criteria

* Any known allergies to the study design

Design outcomes

Primary

Measure	Time frame
Overall analgesic effect over 8 hours	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

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