Clinical trial NCT00671320: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Sprains and Strains
Sprain
Keywords: acute ankle sprain, acute pain, South America
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-05
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Patient's assessment of ankle pain VAS
timeFrame: Day 4
Secondary outcomes:
measure: Time to onset of pain relief
timeFrame: 0, 15, 30, 45, and 60 minutes after first dose
measure: Physician's global assessment of ankle injury
timeFrame: Days 1, 4, and 7
measure: Patient's global assessment of ankle injury
timeFrame: Days 1, 4 and 7
measure: Patient's assessment of normal function/activity
timeFrame: Days 1 to 7
measure: Patient's and physician's satisfaction assessments
timeFrame: Day 7
measure: Patient's assessment of ankle pain on visual analogue scale (VAS)
timeFrame: Days 1 to 7
Other outcomes:
Locations:
city: Avellaneda
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinarmarca
city: Bucaramanga
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle del Cauca
city: Calli
country: Colombia
facility: Pfizer Investigational Site
state: Valle del Cauca
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: