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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ketoprofen 100mg; Drug: Parecoxib 40mg

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, CEP 20551-030
      • Pfizer Investigational Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Pfizer Investigational Site
    • Porto Alegre, RS, Brazil, 90035-003
      • Pfizer Investigational Site
  • SP
    • Ribeirao Preto, SP, Brazil, 14015-130
      • Pfizer Investigational Site
    • Ribeirao Preto, SP, Brazil, 14048-900
      • Pfizer Investigational Site
    • Sao Bernardo do Campo, SP, Brazil, 09715-090
      • Pfizer Investigational Site
    • Sao Paulo, SP, Brazil, 04262-000
      • Pfizer Investigational Site
    • São Paulo, SP, Brazil, 04321-120
      • Pfizer Investigational Site
    • Vila Mariana - São Paulo, SP, Brazil, 04122-000
      • Pfizer Investigational Site
• Chile
  • Santiago, RM
    • Providencia, Santiago, RM, Chile, 7500921
      • Pfizer Investigational Site
• Costa Rica
  • Alajuela, Costa Rica
    • Pfizer Investigational Site
  • San Jose
    • Desamparados, San Jose, Costa Rica
      • Pfizer Investigational Site
    • San José, San Jose, Costa Rica
      • Pfizer Investigational Site
• Ecuador
  • Pichincha
    • Quito, Pichincha, Ecuador
      • Pfizer Investigational Site
• Honduras
  • San Pedro Sula, Honduras
    • Pfizer Investigational Site
• Peru
  • Lima, Peru, L 31
    • Pfizer Investigational Site
  • Lima, Peru, L27
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I; Ketoprofen plus placebo parecoxib	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
Active Comparator: II; Parecoxib plus placebo ketoprofen	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 2, 2007
• First Posted (Estimate): November 4, 2007

Study Record Updates

• Last Update Posted (Estimate): January 28, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Renal Colic Pain Urinary Tract Colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Renal Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Ketoprofen; Parecoxib
• Other Study ID Numbers: A3481065