Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Acute Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 s...
Detailed Description
A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck \& Co Inc
Eligibility Criteria
Inclusion
- 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
- None reported
Key Trial Info
Start Date :
June 4 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2004
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00657449
Start Date
June 4 2003
End Date
October 5 2004
Last Update
November 30 2018
Active Locations (8)
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1
Instituto Ortopedico de Goiania
Goiânia, Goiás, Brazil, 74210-030
2
Centro de Traumatologia e Ortopedia
Goiânia, Goiás, Brazil
3
Hospital Sao Zacarias
Rio de Janeiro, Rio de Janeiro, Brazil
4
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil, 90880480