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A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

NCT ID: NCT00671320

Last Updated: 2008-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-10-31

Brief Summary

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To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.

Detailed Description

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Conditions

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Pain Sprains and Strains Sprain

Keywords

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acute ankle sprain, acute pain, South America

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7

Arm 2

Group Type ACTIVE_COMPARATOR

diclofenac

Intervention Type DRUG

diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Interventions

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valdecoxib

valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7

Intervention Type DRUG

diclofenac

diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients had sprained their ankle within 48 hours
* The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
* At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
* Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms

Exclusion Criteria

* Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
* Patients with a similar injury of the same joint within the last 6 months
* Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
* Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Avellaneda, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

San Isidro, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Santiago, , Chile

Site Status

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Site Status

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Site Status

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Site Status

Pfizer Investigational Site

Bogotá, Cundinarmarca, Colombia

Site Status

Pfizer Investigational Site

Bucaramanga, Santander Department, Colombia

Site Status

Pfizer Investigational Site

Cali, Valle del Cauca Department, Colombia

Site Status

Pfizer Investigational Site

Calli, Valle del Cauca Department, Colombia

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

Lima, Lima Province, Peru

Site Status

Pfizer Investigational Site

Lima, Lima Province, Peru

Site Status

Countries

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Argentina Chile Colombia Mexico Peru

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-146&StudyName=A%20Multi-Center%2C%20Randomized%2C%20Double-Blind%2C%20Parallel%20Group%20Study%20To%20Compare%20The%20Efficacy%20And%20Tolerability%20Of%20Valdecoxib%20And%20Diclofena

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3471037

Identifier Type: -

Identifier Source: secondary_id

VALA-0513-146

Identifier Type: -

Identifier Source: org_study_id