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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00671320

Collaborator

(none)

202

Enrollment

Locations

Arms

Duration (Months)

13.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Sprains and Strains Sprain	Drug: valdecoxib Drug: diclofenac	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2002

Actual Study Completion Date :

Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
Active Comparator: Arm 2	Drug: diclofenac diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: valdecoxib

valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7

Active Comparator: Arm 2

Drug: diclofenac

diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Outcome Measures

Primary Outcome Measures

Patient's assessment of ankle pain VAS [Day 4]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Avellaneda	Buenos Aires	Argentina	1872
2	Pfizer Investigational Site	San Isidro	Buenos Aires	Argentina	1642
3	Pfizer Investigational Site	Buenos Aires		Argentina
4	Pfizer Investigational Site	Santiago	RM	Chile
5	Pfizer Investigational Site	Santiago		Chile
6	Pfizer Investigational Site	Medellin	Antioquia	Colombia	(574) 5141516
7	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	(57) 310-2322198
8	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	(57) 310-8849622
9	Pfizer Investigational Site	Bogota	Cundinarmarca	Colombia	(571) 6 164278
10	Pfizer Investigational Site	Bucaramanga	Santander	Colombia	(577) 6 395409
11	Pfizer Investigational Site	Cali	Valle del Cauca	Colombia	(57) 315-5410469
12	Pfizer Investigational Site	Calli	Valle del Cauca	Colombia	(57) 310-8259712
13	Pfizer Investigational Site	Monterrey	Nuevo Leon	Mexico	64460
14	Pfizer Investigational Site	Lima		Peru	27
15	Pfizer Investigational Site	Lima		Peru