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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00671320
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : May 5, 2008
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : December 2002
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Patient's assessment of ankle pain VAS [ Time Frame: Day 4 ]

Secondary Outcome Measures :
  1. Time to onset of pain relief [ Time Frame: 0, 15, 30, 45, and 60 minutes after first dose ]
  2. Physician's global assessment of ankle injury [ Time Frame: Days 1, 4, and 7 ]
  3. Patient's global assessment of ankle injury [ Time Frame: Days 1, 4 and 7 ]
  4. Patient's assessment of normal function/activity [ Time Frame: Days 1 to 7 ]
  5. Patient's and physician's satisfaction assessments [ Time Frame: Day 7 ]
  6. Patient's assessment of ankle pain on visual analogue scale (VAS) [ Time Frame: Days 1 to 7 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 27
Pfizer Investigational Site
Lima, Peru
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00671320     History of Changes
Other Study ID Numbers: VALA-0513-146
A3471037
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: May 5, 2008
Last Verified: April 2008

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

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