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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00553605
First received: November 2, 2007
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Ketoprofen 100mg
Drug: Parecoxib 40mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Pain Intensity Difference at 30 Minutes (mPID30min) [ Time Frame: Minute 30 ] [ Designated as safety issue: No ]
    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:
  • Mean Pain Intensity Difference at 120 Min (mPID120min) [ Time Frame: Minute 120 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.


Enrollment: 340
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553605

Locations
Brazil
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, CEP 20551-030
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Pfizer Investigational Site
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
Chile
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7500921
Costa Rica
Pfizer Investigational Site
Desamparados, San Jose, Costa Rica
Pfizer Investigational Site
San José, San Jose, Costa Rica
Pfizer Investigational Site
Alajuela, Costa Rica
Ecuador
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Honduras
Pfizer Investigational Site
San Pedro Sula, Honduras
Peru
Pfizer Investigational Site
Lima, Peru, L27
Pfizer Investigational Site
Lima, Peru, L 31
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00553605     History of Changes
Other Study ID Numbers: A3481065
Study First Received: November 2, 2007
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: Ecuador: Public Health Ministry

Keywords provided by Pfizer:
Renal Colic Pain Urinary Tract Colic

Additional relevant MeSH terms:
Renal Colic
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Ketoprofen
Parecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014