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

Pain Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671320
• Other study ID #: VALA-0513-146
• Secondary ID: A3471037
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2008
• Last updated: April 30, 2008
• Start date: December 2002
• Est. completion date: October 2003

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Sprain
• Sprains and Strains

Intervention

Drug:
• valdecoxib
valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
• diclofenac
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Avellaneda	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	San Isidro	Buenos Aires
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bogota	Cundinarmarca
Colombia	Pfizer Investigational Site	Bucaramanga	Santander
Colombia	Pfizer Investigational Site	Cali	Valle del Cauca
Colombia	Pfizer Investigational Site	Calli	Valle del Cauca
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's assessment of ankle pain VAS		Day 4	No
Secondary	Time to onset of pain relief		0, 15, 30, 45, and 60 minutes after first dose	No
Secondary	Physician's global assessment of ankle injury		Days 1, 4, and 7	No
Secondary	Patient's global assessment of ankle injury		Days 1, 4 and 7	No
Secondary	Patient's assessment of normal function/activity		Days 1 to 7	No
Secondary	Patient's and physician's satisfaction assessments		Day 7	No
Secondary	Patient's assessment of ankle pain on visual analogue scale (VAS)		Days 1 to 7	No

External Links

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