Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Pain
Sprains and Strains
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00671320
Start Date
December 1 2002
End Date
October 1 2003
Last Update
May 5 2008
Active Locations (15)
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1
Pfizer Investigational Site
Avellaneda, Buenos Aires, Argentina, 1872
2
Pfizer Investigational Site
San Isidro, Buenos Aires, Argentina, 1642
3
Pfizer Investigational Site
Buenos Aires, Argentina
4
Pfizer Investigational Site
Santiago, RM, Chile