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

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ClinicalTrials.gov Identifier: NCT00553605
Recruitment Status : Completed
First Posted : November 4, 2007
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 2, 2007
First Posted Date  ICMJE November 4, 2007
Results First Submitted Date  ICMJE December 20, 2012
Results First Posted Date  ICMJE January 28, 2013
Last Update Posted Date January 28, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
Mean Pain Intensity Difference at 30 Minutes (mPID30min) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
Mean pain intensity difference assessed by VAS between Time 0 and at 30 minutes after the administration of study medication.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
  • Mean Pain Intensity Difference at 120 Min (mPID120min) [ Time Frame: 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.
  • Time-specific Pain Intensity (PI) VAS Score [ Time Frame: 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 [ Time Frame: 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.
  • Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min) [ Time Frame: 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.
  • Number of Participants With Pain Relief (PR) [ Time Frame: 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 [ Time Frame: 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.
  • Patient's Global Evaluation of Study Medication [ Time Frame: 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.
  • Physician's Global Evaluation of Study Medication [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
  • Mean pain intensity difference at 120 minutes after the administration of study medication.
  • Pain Relief at all post dose time points.
  • Time-specific pain intensity difference (PID).
  • Sum of time interval weighted pain relief scores through the first 2 hours after the<br>administration of study medication (TOTPAR2).
  • Proportion of patients with at least 1 grade improvement in pain relief (PR) 30 minutes after administration of study medication.
  • Patient's global evaluation of study medication at 30 and 120 minutes after the<br>administration of study medication.
  • Physician's global evaluation of study medication at 30 and 120 minutes after the<br>administration of study medication.
  • Time to rescue medication up to 120 minutes after the administration of study<br>medication.
  • Incidence rate of adverse events and serious adverse events.
  • Time-specific pain intensity VAS scores at 30 and 120 minutes.
  • Changes in vital signs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: I
    Ketoprofen plus placebo parecoxib
    Intervention: Drug: Ketoprofen 100mg
  • Active Comparator: II
    Parecoxib plus placebo ketoprofen
    Intervention: Drug: Parecoxib 40mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2012)
340
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2007)
336
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Chile,   Costa Rica,   Ecuador,   Honduras,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553605
Other Study ID Numbers  ICMJE A3481065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP