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

Condition(s) targeted: Pain; Sprains and Strains; Sprain

Intervention: valdecoxib (Drug); diclofenac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Patient's assessment of ankle pain VAS

Secondary outcome:

Time to onset of pain relief

Physician's global assessment of ankle injury

Patient's global assessment of ankle injury

Patient's assessment of normal function/activity

Patient's and physician's satisfaction assessments

Patient's assessment of ankle pain on visual analogue scale (VAS)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Buenos Aires, Argentina

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, Lima 27, Peru

Pfizer Investigational Site, Lima, Peru

Pfizer Investigational Site, Medellin, Antioquia (574) 5141516, Colombia

Pfizer Investigational Site, Avellaneda, Buenos Aires 1872, Argentina

Pfizer Investigational Site, San Isidro, Buenos Aires 1642, Argentina

Pfizer Investigational Site, Bogota, Cundinamarca (57) 310-2322198, Colombia

Pfizer Investigational Site, Bogota, Cundinamarca (57) 310-8849622, Colombia

Pfizer Investigational Site, Bogota, Cundinarmarca (571) 6 164278, Colombia

Pfizer Investigational Site, Monterrey, Nuevo Leon 64460, Mexico

Pfizer Investigational Site, Santiago, RM, Chile

Pfizer Investigational Site, Bucaramanga, Santander (577) 6 395409, Colombia

Pfizer Investigational Site, Calli, Valle del Cauca (57) 310-8259712, Colombia

Pfizer Investigational Site, Cali, Valle del Cauca (57) 315-5410469, Colombia

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

Link to ClinicalStudyResults.org posting:

Starting date: December 2002
Ending date: October 2003
Last updated: April 30, 2008