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

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NCT00446797

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Study Location
Pfizer Investigational Site
Goiânia, GO, 74075-020, Brazil
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankle Sprain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Ankle SprainOpen Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
NCT00446797
  1. Goiânia, GO
  2. Rio de Janeiro, RJ
  3. São Paulo, SP
  4. São Paulo, SP
  5. San Antonio Guadalupe, Guadalupe, San Jose
  6. Quito, Pichincha
  7. Cairo,
  8. Amman,
  9. Amman,
  10. Amman,
  11. Mexico, DF
  12. Toluca, Estado de México
  13. México DF, México
  14. San Nicolas de los Garza, Nuevo León
  15. Panama City,
  16. Lima,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Official Title  ICMJE An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Drug: Non-selective NSAIDS
    Non-selective NSAIDs administered at usual (standard) doses.
  • Drug: Celecoxib
    celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Study Arms  ICMJE
  • Active Comparator: Non-Selective NSAIDS
    nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
    Intervention: Drug: Non-selective NSAIDS
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
Publications * 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:CD007789. doi: 10.1002/14651858.CD007789.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2009)		278
Original Enrollment  ICMJE
 (submitted: March 9, 2007)		222
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Costa Rica,   Ecuador,   Egypt,   Jordan,   Mexico,   Panama,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446797
Other Study ID Numbers  ICMJE A3191332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP