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Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic

Last updated on October 5, 2018

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Study Location
Pfizer Investigational Site
Rio de Janeiro, RJ, CEP 20551-030 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient male or female with a confirmed diagnosis of acute renal colic with moderate
to severe pain according to the VAS and Categoric pain scales

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

- The patient has significant renal or hepatic conditions other than uncomplicated
kidney stones.

- 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.

NCT00553605
Pfizer
Completed
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic

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Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: 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
  • Drug: 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
  • Active Comparator: I
    Ketoprofen plus placebo parecoxib
    Intervention: Drug: Ketoprofen 100mg
  • Active Comparator: II
    Parecoxib plus placebo ketoprofen
    Intervention: Drug: Parecoxib 40mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales

Exclusion Criteria:

  • The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile,   Costa Rica,   Ecuador,   Honduras,   Peru
 
 
NCT00553605
A3481065
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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