Clinical trial NCT00553605: Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Renal Colic Pain Urinary Tract Colic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Pain Intensity Difference at 30 Minutes (mPID30min)
timeFrame: Minute 30
Secondary outcomes:
measure: Mean Pain Intensity Difference at 120 Min (mPID120min)
timeFrame: Minute 120
measure: Time-specific Pain Intensity (PI) VAS Score
timeFrame: Baseline, Minute 15, 30, 45, 60, 90, 120
measure: Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120
timeFrame: Baseline, Minute 15, 30, 45, 60, 90, 120
measure: Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)
timeFrame: Baseline through Minute 120
measure: Number of Participants With Pain Relief (PR)
timeFrame: Minute 30, 120
measure: Number of Participants With Response in Pain Intensity
timeFrame: Minute 30
measure: Patient's Global Evaluation of Study Medication
timeFrame: Minute 30, 120
measure: Physician's Global Evaluation of Study Medication
timeFrame: Minute 30, 120
measure: Number of Participants With Use of Rescue Medication (RM)
timeFrame: Up to Minute 120
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Ribeirao Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Bernardo do Campo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Vila Mariana - São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Desamparados
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San José
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Alajuela
country: Costa Rica
facility: Pfizer Investigational Site
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: San Pedro Sula
country: Honduras
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: