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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 2, 2007
• First Posted Date: November 4, 2007
• Results First Submitted Date: December 20, 2012
• Results First Posted Date: January 28, 2013
• Last Update Posted Date: January 28, 2013
• Study Start Date: June 2007
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: November 2, 2007): Mean pain intensity difference assessed by VAS between Time 0 and at 30 minutes after the administration of study medication.

Current Secondary Outcome Measures (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 (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: Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

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
• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2012): 340
• Original Estimated Enrollment (submitted: November 2, 2007): 336
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, Chile, Costa Rica, Ecuador, Honduras, Peru

Administrative Information

• NCT Number: NCT00553605
• Other Study ID Numbers: A3481065
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2012