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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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I

Ketoprofen plus placebo parecoxib

Group Type ACTIVE_COMPARATOR

Ketoprofen 100mg

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Parecoxib 40mg

Intervention Type DRUG

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

Ribeirão Preto, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Ribeirão Preto, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Bernardo do Campo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Vila Mariana - São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Providencia, Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Alajuela, Alajuela Province, Costa Rica

Site Status

Pfizer Investigational Site

Desamparados, Provincia de San José, Costa Rica

Site Status

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Site Status

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Site Status

Pfizer Investigational Site

San Pedro Sula, San Pedro Sula, Honduras

Site Status

Pfizer Investigational Site

Lima, Lima Province, Peru

Site Status

Pfizer Investigational Site

Lima, Lima Province, Peru

Site Status

Countries

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Brazil Chile Costa Rica Ecuador Honduras Peru

Related Links

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Other Identifiers

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A3481065

Identifier Type: -

Identifier Source: org_study_id

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