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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ketoprofen 100mg
Parecoxib 40mg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Renal Colic Pain Urinary Tract Colic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

I

II

Arm Description

Ketoprofen plus placebo parecoxib

Parecoxib plus placebo ketoprofen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 2, 2007
Last Updated
December 20, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00553605
Brief Title
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Acronym
NAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Renal Colic Pain Urinary Tract Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Ketoprofen plus placebo parecoxib
Arm Title
II
Arm Type
Active Comparator
Arm Description
Parecoxib plus placebo ketoprofen
Intervention Type
Drug
Intervention Name(s)
Ketoprofen 100mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Parecoxib 40mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Pain Intensity Difference at 30 Minutes (mPID30min)
Description
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.
Time Frame
Minute 30
Secondary Outcome Measure Information:
Title
Mean Pain Intensity Difference at 120 Min (mPID120min)
Description
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 Frame
Minute 120
Title
Time-specific Pain Intensity (PI) VAS Score
Description
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 Frame
Baseline, Minute 15, 30, 45, 60, 90, 120
Title
Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120
Description
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 Frame
Baseline, Minute 15, 30, 45, 60, 90, 120
Title
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)
Description
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.
Time Frame
Baseline through Minute 120
Title
Number of Participants With Pain Relief (PR)
Description
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.
Time Frame
Minute 30, 120
Title
Number of Participants With Response in Pain Intensity
Description
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.
Time Frame
Minute 30
Title
Patient's Global Evaluation of Study Medication
Description
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.
Time Frame
Minute 30, 120
Title
Physician's Global Evaluation of Study Medication
Description
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.
Time Frame
Minute 30, 120
Title
Number of Participants With Use of Rescue Medication (RM)
Description
Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.
Time Frame
Up to Minute 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
CEP 20551-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Bernardo do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04262-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04321-120
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Vila Mariana - São Paulo
State/Province
SP
ZIP/Postal Code
04122-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago, RM
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pfizer Investigational Site
City
Desamparados
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San José
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Alajuela
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
San Pedro Sula
Country
Honduras
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L 31
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L27
Country
Peru

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3481065&StudyName=Efficacy%20And%20Safety%20Of%20Parecoxib%2040mg%20vs.%20Ketoprofen%20100mg%20In%20The%20Management%20Of%20Acute%20Renal%20Colic
Description
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Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic

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