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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Ketoprofen 100mg; Drug: Parecoxib 40mg

• Registration Number: NCT00553605
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-12
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Results First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Ketoprofen 100mg	Ketoprofen plus placebo parecoxib
II	Parecoxib 40mg	Parecoxib plus placebo ketoprofen

Primary Outcome Measures

Name	Time	Method
Mean Pain Intensity Difference at 30 Minutes (mPID30min)	Minute 30	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Pain Relief (PR)	Minute 30, 120	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.
Number of Participants With Response in Pain Intensity	Minute 30	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.
Mean Pain Intensity Difference at 120 Min (mPID120min)	Minute 120	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.
Patient's Global Evaluation of Study Medication	Minute 30, 120	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.
Time-specific Pain Intensity (PI) VAS Score	Baseline, Minute 15, 30, 45, 60, 90, 120	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.
Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120	Baseline, Minute 15, 30, 45, 60, 90, 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.
Physician's Global Evaluation of Study Medication	Minute 30, 120	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.
Number of Participants With Use of Rescue Medication (RM)	Up to Minute 120	Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)	Baseline through Minute 120	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇪 Lima, Peru