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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00671320
First received: March 31, 2008
Last updated: April 30, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Pain
Sprains and Strains
Sprain
Drug: valdecoxib
Drug: diclofenac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's assessment of ankle pain VAS [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of pain relief [ Time Frame: 0, 15, 30, 45, and 60 minutes after first dose ] [ Designated as safety issue: No ]
  • Physician's global assessment of ankle injury [ Time Frame: Days 1, 4, and 7 ] [ Designated as safety issue: No ]
  • Patient's global assessment of ankle injury [ Time Frame: Days 1, 4 and 7 ] [ Designated as safety issue: No ]
  • Patient's assessment of normal function/activity [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
  • Patient's and physician's satisfaction assessments [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Patient's assessment of ankle pain on visual analogue scale (VAS) [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: December 2002
Study Completion Date: October 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671320

Locations
Argentina
Pfizer Investigational Site
Avellaneda, Buenos Aires, Argentina, 1872
Pfizer Investigational Site
San Isidro, Buenos Aires, Argentina, 1642
Pfizer Investigational Site
Buenos Aires, Argentina
Chile
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Santiago, Chile
Colombia
Pfizer Investigational Site
Medellin, Antioquia, Colombia, (574) 5141516
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia, (57) 310-2322198
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia, (57) 310-8849622
Pfizer Investigational Site
Bogota, Cundinarmarca, Colombia, (571) 6 164278
Pfizer Investigational Site
Bucaramanga, Santander, Colombia, (577) 6 395409
Pfizer Investigational Site
Cali, Valle del Cauca, Colombia, (57) 315-5410469
Pfizer Investigational Site
Calli, Valle del Cauca, Colombia, (57) 310-8259712
Mexico
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Peru
Pfizer Investigational Site
Lima, Peru
Pfizer Investigational Site
Lima, Peru, 27
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00671320     History of Changes
Other Study ID Numbers: VALA-0513-146, A3471037
Study First Received: March 31, 2008
Last Updated: April 30, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Pfizer:
acute ankle sprain, acute pain, South America

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Diclofenac
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014