A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00657449

Collaborator

(none)

Enrollment

Locations

Arms

16.1

Actual Duration (Months)

5.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: valdecoxib Drug: rofecoxib	Phase 4

Detailed Description

A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck & Co Inc

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Double-dummy, Multicenter Randomized Study Of The Efficacy And The Tolerability Of Valdecoxib 40mg Vs Rofecoxib 50mg In The Symptomatic Treatment Of Patients With Ankle Sprain

Actual Study Start Date :

Jun 4, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 5, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
Active Comparator: Arm 2	Drug: rofecoxib rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: valdecoxib

valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8

Active Comparator: Arm 2

Drug: rofecoxib

rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days

Outcome Measures

Primary Outcome Measures

change from baseline in visual analogue scale (VAS) pain intensity [Day 4]

Secondary Outcome Measures

patient's assessment of ankle pain VAS (0-100 mm) [Days 1, 4 and 8]
patient's and physician's global assessment of ankle injury [Days 1, 4 and 8]
patient's and physician's satisfaction assessments [Day 8]
patient's assessment of normal function/activity [Days 1, 4 and 8]
adverse events, physical examinations, and baseline clinical laboratory values [Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion Criteria:

None reported

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Ortopedico de Goiania	Goiania	Goias	Brazil	74210-030
2	Centro de Traumatologia e Ortopedia	Goiania	Goiás	Brazil
3	Hospital Mãe de Deus	Porto Alegre	RIO Grande DO SUL	Brazil	90880480
4	Hospital Sao Zacarias	Rio de Janeiro	RJ	Brazil
5	Grupo Hospitalar Conceiçao	Porto Alegre	RS	Brazil	91350200
6	Hospital Geral do Grajau	São Paulo	SP	Brazil	04822-320
7	Unifesp - Hsp	São Paulo		Brazil	04063003
8	SECONCI	São Paulo		Brazil	05001000