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

Phase 4

Completed

• Conditions: Pain; Sprains and Strains; Sprain
• Interventions: Drug: valdecoxib; Drug: diclofenac

• Registration Number: NCT00671320
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2003-10
• Study First Submitted: 2008-03-31
• Status Verified: 2008-04
• Study First Submitted QC: 2008-04-30
• Last Update Submitted: 2008-04-30
• Study First Posted: 2008-05-05
• Last Update Posted: 2008-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	valdecoxib	-
Arm 2	diclofenac	-

Primary Outcome Measures

Name	Time	Method
Patient's assessment of ankle pain VAS	Day 4

Secondary Outcome Measures

Name	Time	Method
Time to onset of pain relief	0, 15, 30, 45, and 60 minutes after first dose
Physician's global assessment of ankle injury	Days 1, 4, and 7
Patient's global assessment of ankle injury	Days 1, 4 and 7
Patient's assessment of normal function/activity	Days 1 to 7
Patient's and physician's satisfaction assessments	Day 7
Patient's assessment of ankle pain on visual analogue scale (VAS)	Days 1 to 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇪 Lima, Peru