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Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446797
First Posted: March 13, 2007
Last Update Posted: July 29, 2009
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.
Information provided by:
Pfizer
  Purpose
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.

Condition Intervention Phase
Ankle Sprain Drug: Non-selective NSAIDS Drug: Celecoxib Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population [ Time Frame: Baseline and day 3 ]

Secondary Outcome Measures:
  • Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population [ Time Frame: Baseline and days 2, 3 and 7 ]
  • Number of Subjects Responding (Improving) - MITT Population [ Time Frame: Days 2, 3 and 7 ]
  • Subject's Global Assessment of Ankle Injury [ Time Frame: Days 2, 3 and 7 ]
  • Physician Global Assessment of Ankle Injury [ Time Frame: Days 3 and 7 ]
  • Pain Relief - MITT Population [ Time Frame: Days 2, 3 and 7 ]
  • Subject Assessment of Normal Function / Activity [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 [ Time Frame: Days 1, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G [ Time Frame: Days 2, 3 and 7 ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index [ Time Frame: Days 2, 3 and 7 ]

Enrollment: 278
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-Selective NSAIDS
nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
Drug: Non-selective NSAIDS
Non-selective NSAIDs administered at usual (standard) doses.
Experimental: Celecoxib Drug: Celecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
  • Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
  • Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.

Exclusion Criteria:

  • Patients who have a similar injury of the same joint within the last six months; or
  • clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
  • requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
  • evidence of fractures; or non-removable full cast of any tipe; or
  • presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
  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): NCT00446797


Locations
Brazil
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20221-161
Pfizer Investigational Site
São Paulo, SP, Brazil, 01221-900
Pfizer Investigational Site
São Paulo, SP, Brazil, 02720-000
Costa Rica
Pfizer Investigational Site
San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica
Ecuador
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Egypt
Pfizer Investigational Site
Cairo, Egypt
Jordan
Pfizer Investigational Site
Amman, Jordan, 11181 Jordan
Pfizer Investigational Site
Amman, Jordan, 11193 Jordan
Pfizer Investigational Site
Amman, Jordan, 22110 Jordan
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 10700
Pfizer Investigational Site
Toluca, Estado de México, Mexico, 50180
Pfizer Investigational Site
México DF, México, Mexico, 03020
Pfizer Investigational Site
San Nicolas de los Garza, Nuevo León, Mexico, 66451
Panama
Pfizer Investigational Site
Panama City, Panama
Peru
Pfizer Investigational Site
Lima, Peru, L27
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: NCT00446797     History of Changes
Other Study ID Numbers: A3191332
First Submitted: March 9, 2007
First Posted: March 13, 2007
Results First Submitted: April 21, 2009
Results First Posted: June 10, 2009
Last Update Posted: July 29, 2009
Last Verified: June 2009

Keywords provided by Pfizer:
Ankle sprain, acute pain, NSAID, celecoxib,

Additional relevant MeSH terms:
Acute Pain
Sprains and Strains
Ankle Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries
Leg Injuries
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents