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

NCT00671320 | Completed Phase 4

• 2 other identifiers: VALA-0513-146A3471037
• Study Type: interventional
• Target: 202
• Locations: 5 countries
• Sites: 15

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.

Conditions

Pain; Sprains and Strains; Sprain

Keywords

acute ankle sprain, acute pain, South America

Outcome Measures

Primary Outcomes (1)

• Patient's assessment of ankle pain VAS

  Day 4

Secondary Outcomes (6)

• 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: diclofenac

Interventions

valdecoxib DRUG

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

Arm 1

diclofenac DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Pfizer Investigational Site

Avellaneda, Buenos Aires, 1872, Argentina

Location

Pfizer Investigational Site

San Isidro, Buenos Aires, 1642, Argentina

Location

Pfizer Investigational Site

Buenos Aires, Argentina

Location

Pfizer Investigational Site

Santiago, RM, Chile

Location

Pfizer Investigational Site

Santiago, Chile

Location

Pfizer Investigational Site

Medellín, Antioquia, (574) 5141516, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, (57) 310-2322198, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, (57) 310-8849622, Colombia

Location

Pfizer Investigational Site

Bogotá, Cundinarmarca, (571) 6 164278, Colombia

Location

Pfizer Investigational Site

Bucaramanga, Santander Department, (577) 6 395409, Colombia

Location

Pfizer Investigational Site

Cali, Valle del Cauca Department, (57) 315-5410469, Colombia

Location

Pfizer Investigational Site

Calli, Valle del Cauca Department, (57) 310-8259712, Colombia

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Lima, Lima Province, 27, Peru

Location

Pfizer Investigational Site

Lima, Lima Province, Peru

Location

Related Links

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

MeSH Terms

Conditions

Pain; Sprains and Strains; Acute Pain

Interventions

valdecoxib; Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: May 5, 2008
• Study Start: December 1, 2002
• Study Completion: October 1, 2003
• Last Updated: May 5, 2008

Record last verified: 2008-04

Locations

CL (2); AR (3); PE (2); ME (1); CO (7)