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

Study Overview
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketoprofen 100mg
* Drug: Parecoxib 40mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Ketoprofen plus placebo parecoxib | Drug: Ketoprofen 100mg<br>* 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<br>|
| Active Comparator: II<br>Parecoxib plus placebo ketoprofen | Drug: Parecoxib 40mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Colic Pain Urinary Tract Colic