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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00446797

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: Diclofenac Drug: Celecoxib	Phase IV

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change of patient's assessment of pain due to ankle sprain on the visual analog scale (VAS) from baseline to day 3. [ Time Frame: Baseline to day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with at least one grade improvement in pain relief (PR) at 24 hours, day 3 and day 7. [ Time Frame: 24 hours, Days 3 and 7 ] [ Designated as safety issue: No ]
Physician's global assessment of ankle injury at Day 3 and Day 7 [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: No ]
Patient's assessment of normal function/activity score at 24 hours, Day 3 and day 7. [ Time Frame: 24 hours, Days 3 and 7 ] [ Designated as safety issue: No ]
Patient's responses to modified Brief Pain Inventory-Short Form (m.BPI-sf) individual items, pain severity composite, and pain interference composite scores, at 24 hours, Day 3 and Day 7. [ Time Frame: 24 hours, Days 3 and 7 ] [ Designated as safety issue: No ]
Responder rates (the proportion of patients improving by at least 20mm an the VAS scale at 24 hours,Day 3 and Day 7. [ Time Frame: 24 hours, Day 3 and Day 7 ] [ Designated as safety issue: No ]
Patient's global assessment of ankle injury at 24 hours, Day 3 and Day 7 [ Time Frame: 24 hours, Days 3 and Day 7 ] [ Designated as safety issue: No ]
Change from baseline in pain VAS score at 24 hours and Day 7 [ Time Frame: 24 hours and Day 7 ] [ Designated as safety issue: No ]

Enrollment:	258
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
Non-Selective NSAIDS: Active Comparator nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.	Drug: Diclofenac Capsules, 100 mg, 1 - 2 capsules per day for 7 days.
Celecoxib: Experimental	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, GO
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Brazil, RJ
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20221-161
Brazil, SP
Pfizer Investigational Site
São Paulo, SP, Brazil, 01221-900
Pfizer Investigational Site
São Paulo, SP, Brazil, 02720-000
Costa Rica, Guadalupe, San Jose
Pfizer Investigational Site
San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica
Ecuador, Pichincha
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Egypt
Pfizer Investigational Site
Cairo, 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, DF
Pfizer Investigational Site
Mexico, DF, Mexico, 10700
Mexico, Estado de México
Pfizer Investigational Site
Toluca, Estado de México, Mexico, 50180
Mexico, México
Pfizer Investigational Site
México DF, México, Mexico, 03020
Mexico, Nuevo León
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
Pfizer Investigational Site
Lima, Peru, L27

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191332
Study First Received:	March 9, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00446797
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Pfizer:

Ankle sprain, acute pain, NSAID, celecoxib,

Study placed in the following topic categories:

Celecoxib
Wounds and Injuries
Diclofenac

Disorders of Environmental Origin
Pain
Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009