Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
NCT ID: NCT00553605
Last Updated: 2013-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
340 participants
INTERVENTIONAL
2007-06-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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I
Ketoprofen plus placebo parecoxib
Ketoprofen 100mg
Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
II
Parecoxib plus placebo ketoprofen
Parecoxib 40mg
Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
Interventions
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Ketoprofen 100mg
Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
Parecoxib 40mg
Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
Ribeirão Preto, São Paulo, Brazil
Pfizer Investigational Site
Ribeirão Preto, São Paulo, Brazil
Pfizer Investigational Site
São Bernardo do Campo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Vila Mariana - São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Providencia, Santiago, RM, Chile
Pfizer Investigational Site
Alajuela, Alajuela Province, Costa Rica
Pfizer Investigational Site
Desamparados, Provincia de San José, Costa Rica
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Pfizer Investigational Site
San Pedro Sula, San Pedro Sula, Honduras
Pfizer Investigational Site
Lima, Lima Province, Peru
Pfizer Investigational Site
Lima, Lima Province, Peru
Countries
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Related Links
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Other Identifiers
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A3481065
Identifier Type: -
Identifier Source: org_study_id
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