Clinical trial NCT00446797: Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprain
Keywords: Ankle sprain, acute pain, NSAID, celecoxib,
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
timeFrame: Baseline and day 3
Secondary outcomes:
measure: Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
timeFrame: Baseline and days 2, 3 and 7
measure: Number of Subjects Responding (Improving) - MITT Population
timeFrame: Days 2, 3 and 7
measure: Subject's Global Assessment of Ankle Injury
timeFrame: Days 2, 3 and 7
measure: Physician Global Assessment of Ankle Injury
timeFrame: Days 3 and 7
measure: Pain Relief - MITT Population
timeFrame: Days 2, 3 and 7
measure: Subject Assessment of Normal Function / Activity
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
timeFrame: Days 1, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
timeFrame: Days 2, 3 and 7
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
timeFrame: Days 2, 3 and 7
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: San Antonio Guadalupe
country: Costa Rica
facility: Pfizer Investigational Site
state: Guadalupe, San Jose
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Toluca
country: Mexico
facility: Pfizer Investigational Site
state: Estado De México
city: San Nicolas de los Garza
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo León
city: México DF
country: Mexico
facility: Pfizer Investigational Site
city: Panama City
country: Panama
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.