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

Last updated on March 22, 2018

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Study Location
Pfizer Investigational Site
Goiânia, GO, 74075-020 Brazil
Contact
1-800-718-1021
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.

NCT00446797
Pfizer
Completed
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

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Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ankle Sprain
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Costa Rica,   Ecuador,   Egypt,   Jordan,   Mexico,   Panama,   Peru
 
 
NCT00446797
A3191332
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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