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

Pain Clinical Trial

— NAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553605
• Other study ID #: A3481065
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2007
• Last updated: December 20, 2012
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Public Health Ministry
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Renal Colic

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Ribeirao Preto	SP
Brazil	Pfizer Investigational Site	Ribeirao Preto	SP
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Bernardo do Campo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	Vila Mariana - São Paulo	SP
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
Costa Rica	Pfizer Investigational Site	Alajuela
Costa Rica	Pfizer Investigational Site	Desamparados	San Jose
Costa Rica	Pfizer Investigational Site	San José	San Jose
Ecuador	Pfizer Investigational Site	Quito	Pichincha
Honduras	Pfizer Investigational Site	San Pedro Sula
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Brazil,  Chile,  Costa Rica,  Ecuador,  Honduras,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Intensity Difference at 30 Minutes (mPID30min)	mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.	Minute 30	No
Secondary	Mean Pain Intensity Difference at 120 Min (mPID120min)	mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.	Minute 120	No
Secondary	Time-specific Pain Intensity (PI) VAS Score	PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.	Baseline, Minute 15, 30, 45, 60, 90, 120	No
Secondary	Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120	PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.	Baseline, Minute 15, 30, 45, 60, 90, 120	No
Secondary	Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)	TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.	Baseline through Minute 120	No
Secondary	Number of Participants With Pain Relief (PR)	PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.	Minute 30, 120	No
Secondary	Number of Participants With Response in Pain Intensity	PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.	Minute 30	No
Secondary	Patient's Global Evaluation of Study Medication	Participants' response to the question "How would you rate the study medication you received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.	Minute 30, 120	No
Secondary	Physician's Global Evaluation of Study Medication	Physicians' response to the question "How would you rate the study medication the patient received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.	Minute 30, 120	No
Secondary	Number of Participants With Use of Rescue Medication (RM)	Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.	Up to Minute 120	No

External Links

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