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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00446797
First received: March 9, 2007
Last updated: June 12, 2009
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Number of Subjects Responding (Improving) - MITT Population [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Subject's Global Assessment of Ankle Injury [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Physician Global Assessment of Ankle Injury [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: No ]
  • Pain Relief - MITT Population [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Subject Assessment of Normal Function / Activity [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1 [ Time Frame: Days 1, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2 [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3 [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4 [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index [ Time Frame: Days 2, 3 and 7 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 22110 Jordan
Pfizer Investigational Site
Amman, Jordan, 11193 Jordan
Pfizer Investigational Site
Amman, Jordan, 11181 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00446797     History of Changes
Other Study ID Numbers: A3191332
Study First Received: March 9, 2007
Results First Received: April 21, 2009
Last Updated: June 12, 2009
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
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 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014