Pain, Sprains and Strains, Sprain
Conditions
Keywords
acute ankle sprain, acute pain, South America
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.
Interventions
DRUGvaldecoxib
valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
DRUGdiclofenac
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's assessment of ankle pain VAS | Day 4 |
Secondary
| Measure | Time frame |
|---|---|
| Physician's global assessment of ankle injury | Days 1, 4, and 7 |
| Patient's global assessment of ankle injury | Days 1, 4 and 7 |
| Time to onset of pain relief | 0, 15, 30, 45, and 60 minutes after first dose |
| Patient's and physician's satisfaction assessments | Day 7 |
| Patient's assessment of ankle pain on visual analogue scale (VAS) | Days 1 to 7 |
| Patient's assessment of normal function/activity | Days 1 to 7 |
Countries
Argentina, Chile, Colombia, Mexico, Peru
Outcome results
None listed