CClinicalTrials.gg
Sign In
CompletedNCT00553605NAPUpdated Jan 28, 2013Results posted

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

A Phase 4 interventional study of Ketoprofen 100mg and Parecoxib 40mg in Pain, sponsored by Pfizer. Completed at 17 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-28.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
340
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Browse trials for

Keywords

  • Renal Colic Pain Urinary Tract Colic
03

In context

Renal Colic

80 studies on the registry are indexed under Renal Colic; 10 are open to participants now.

This study's enrollment of 340 is above the median of 107 across 60 interventional studies indexed under Renal Colic.

Browse Renal Colic studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
340 participants (actual)

Study arms

  • Active comparator
    I

    Ketoprofen plus placebo parecoxib

    Drug: Ketoprofen 100mg

  • Active comparator
    II

    Parecoxib plus placebo ketoprofen

    Drug: Parecoxib 40mg

Interventions

  • DrugKetoprofen 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

  • DrugParecoxib 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Minute 30

Secondary outcomes

  1. 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 frame: Minute 120

  2. 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 frame: Baseline, Minute 15, 30, 45, 60, 90, 120

  3. 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 frame: Baseline, Minute 15, 30, 45, 60, 90, 120

  4. 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.

    Time frame: Baseline through Minute 120

  5. 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.

    Time frame: Minute 30, 120

  6. 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.

    Time frame: Minute 30

  7. 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.

    Time frame: Minute 30, 120

  8. 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.

    Time frame: Minute 30, 120

  9. 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.

    Time frame: Up to Minute 120

07

Results

Posted Jan 28, 2013
Limitations and caveats
PR at all time points, proportion of participants with \>= 1 grade improvement in PR 30 min were replaced by PR at 30 and 120 min; number of participants with response in PI included; time to RM reported as number, due to change in planned analysis.

Participant flow

Participant flow — Overall Study
MilestoneParecoxibKetoprofen
Started176164
Treated174164
Completed172161
Not completed43
Withdrew: Did not meet entrance criteria13
Withdrew: Did not receive full dose10
Withdrew: Randomized but not treated20

Outcome measures

PrimaryMean 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.

Time frame:
Minute 30
Reported as:
Least squares mean · mm
Mean Pain Intensity Difference at 30 Minutes (mPID30min)
mmParecoxibKetoprofen
Mean Pain Intensity Difference at 30 Minutes (mPID30min)34.147 ± 3.3535.266 ± 3.46
Statistical analysis
  • Parecoxib vs Ketoprofen · Least-squares (ls) mean difference: -1.12 · 95% CI -6.53 to 4.30
SecondaryMean 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 frame:
Minute 120
Reported as:
Least squares mean · mm
Mean Pain Intensity Difference at 120 Min (mPID120min)
mmParecoxibKetoprofen
Mean Pain Intensity Difference at 120 Min (mPID120min)51.608 ± 2.0251.697 ± 2.05
Statistical analysis
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.972 · Ls mean difference: -0.09 · 95% CI -5.04 to 4.86
SecondaryTime-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 frame:
Baseline, Minute 15, 30, 45, 60, 90, 120
Reported as:
Mean · mm
Time-specific Pain Intensity (PI) VAS Score
mmParecoxibKetoprofen
Baseline (n= 173, 164)77.14 ± 17.9276.99 ± 18.26
Minute 15 (n= 173, 164)50.42 ± 26.9250.95 ± 24.65
Minute 30 (n= 172, 162)34.13 ± 28.5733.65 ± 26.64
Minute 45 (n= 163, 156)21.75 ± 24.8923.15 ± 24.93
Minute 60 (n= 156, 152)14.62 ± 21.2517.53 ± 23.17
Minute 90 (n= 151, 144)9.80 ± 17.1612.27 ± 20.22
Minute 120 (n= 147, 139)7.68 ± 14.298.02 ± 15.26
SecondaryTime-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 frame:
Baseline, Minute 15, 30, 45, 60, 90, 120
Reported as:
Mean · mm
Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120
mmParecoxibKetoprofen
Minute 15 (n= 173, 164)26.72 ± 24.5926.04 ± 26.13
Minute 30 (n= 172, 162)42.89 ± 28.7043.22 ± 29.39
Minute 45 (n= 163, 156)54.37 ± 27.8253.55 ± 27.98
Minute 60 (n= 156, 152)61.35 ± 25.4459.34 ± 26.28
Minute 90 ( n= 151, 144)65.99 ± 22.8864.33 ± 25.05
Minute 120 (n= 147, 139)68.07 ± 21.1468.51 ± 21.21
Statistical analysis
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.768 · Ls mean difference: 0.75 · 95% CI -4.28 to 5.79
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.866 · Ls mean difference: -0.49 · 95% CI -6.22 to 5.24
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.729 · Ls mean difference: 0.94 · 95% CI -4.38 to 6.26
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.290 · Ls mean difference: 2.62 · 95% CI -2.24 to 7.48
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.314 · Ls mean difference: 2.16 · 95% CI -2.05 to 6.37
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.926 · Ls mean difference: 0.16 · 95% CI -3.23 to 3.55
SecondaryTime-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.

Time frame:
Baseline through Minute 120
Reported as:
Least squares mean · units on a scale
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)
units on a scaleParecoxibKetoprofen
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)362.42 ± 10.65352.29 ± 10.85
Statistical analysis
  • Parecoxib vs Ketoprofen · ANCOVA · p = 0.451 · Ls mean difference: 10.13 · 95% CI -16.3 to 36.54
SecondaryNumber 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.

Time frame:
Minute 30, 120
Reported as:
Number · participants
Number of Participants With Pain Relief (PR)
participantsParecoxibKetoprofen
Minute 30: none (n= 171, 162)109
Minute 30: a little (n= 171, 162)2119
Minute 30: some (n= 171, 162)3544
Minute 30: a lot (n= 171, 162)7465
Minute 30: complete (n= 171, 162)3125
Minute 120: none (n= 146, 139)11
Minute 120: a little (n= 146, 139)04
Minute 120: some (n= 146, 139)168
Minute 120: a lot (n= 146, 139)4046
Minute 120: complete (n= 146, 139)8980
Statistical analysis
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.3982
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.5552
SecondaryNumber 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.

Time frame:
Minute 30
Reported as:
Number · participants
Number of Participants With Response in Pain Intensity
participantsParecoxibKetoprofen
Number of Participants With Response in Pain Intensity132124
Statistical analysis
  • Parecoxib vs Ketoprofen · Regression, Logistic · p = 0.9785 · Odds ratio (or): 1.007 · 95% CI 0.60 to 1.69
SecondaryPatient'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.

Time frame:
Minute 30, 120
Reported as:
Number · participants
Patient's Global Evaluation of Study Medication
participantsParecoxibKetoprofen
Minute 30: poor1210
Minute 30: fair2117
Minute 30: good7666
Minute 30: excellent6370
Minute 120: poor85
Minute 120: fair1616
Minute 120: good4946
Minute 120: excellent9896
Statistical analysis
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.2482
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.7659
SecondaryPhysician'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.

Time frame:
Minute 30, 120
Reported as:
Number · participants
Physician's Global Evaluation of Study Medication
participantsParecoxibKetoprofen
Minute 30: poor1111
Minute 30: fair2223
Minute 30: good6963
Minute 30: excellent7066
Minute 120: poor88
Minute 120: fair1415
Minute 120: good4545
Minute 120: excellent10495
Statistical analysis
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.9783
  • Parecoxib vs Ketoprofen · Cochran-Mantel-Haenszel · p = 0.6847
SecondaryNumber 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.

Time frame:
Up to Minute 120
Reported as:
Number · participants
Number of Participants With Use of Rescue Medication (RM)
participantsParecoxibKetoprofen
Number of Participants With Use of Rescue Medication (RM)2625
Statistical analysis
  • Parecoxib vs Ketoprofen · Log Rank · p = 0.9645

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Parecoxib—9/174 (5.2%)47/174 (27%)
Ketoprofen—8/164 (4.9%)55/164 (33.5%)
Most frequent serious events
Most frequent serious events
EventParecoxibKetoprofen
Renal colicRenal and urinary disorders2/1747/164
Condition aggravatedGeneral disorders0/1741/164
Abdominal painGastrointestinal disorders1/1740/164
ColitisGastrointestinal disorders1/1740/164
Urinary tract infectionInfections and infestations1/1740/164
Drug exposure during pregnancyInjury, poisoning and procedural complications1/1740/164
Calculus uretericRenal and urinary disorders1/1740/164
HydronephrosisRenal and urinary disorders1/1740/164
Ureteric obstructionRenal and urinary disorders1/1740/164
Most frequent other events
Showing 10 of 31
Most frequent other events
EventParecoxibKetoprofen
PainGeneral disorders6/1749/164
NauseaGastrointestinal disorders7/1745/164
DizzinessNervous system disorders7/1742/164
VomitingGastrointestinal disorders4/1745/164
Abdominal painGastrointestinal disorders2/1744/164
FlatulenceGastrointestinal disorders0/1744/164
HeadacheNervous system disorders3/1744/164
Back painMusculoskeletal and connective tissue disorders2/1743/164
PyrexiaGeneral disorders3/1741/164
Renal colicRenal and urinary disorders3/1740/164

Baseline characteristics

Age, Customized
Age, Customized(participants)ParecoxibKetoprofenTotal
Less than (<) 18 years101
18 to 44 years131109240
45 to 64 years415495
Greater than or equal to (>=) 65 years112
Sex: Female, Male
Sex: Female, Male(Participants)ParecoxibKetoprofenTotal
Female6461125
Male110103213
08

Study locations

17 sites
  • Pfizer Investigational Site
    Rio de Janeiro, RJ CEP 20551-030, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90035-003, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90610-000, Brazil
  • Pfizer Investigational Site
    Ribeirao Preto, SP 14015-130, Brazil
  • Pfizer Investigational Site
    Ribeirao Preto, SP 14048-900, Brazil
  • Pfizer Investigational Site
    Sao Bernardo do Campo, SP 09715-090, Brazil
  • Pfizer Investigational Site
    Sao Paulo, SP 04262-000, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 04321-120, Brazil
  • Pfizer Investigational Site
    Vila Mariana - São Paulo, SP 04122-000, Brazil
  • Pfizer Investigational Site
    Providencia, Santiago, RM 7500921, Chile
  • Pfizer Investigational Site
    Desamparados, San Jose, Costa Rica
  • Pfizer Investigational Site
    San José, San Jose, Costa Rica
  • Pfizer Investigational Site
    Alajuela, Costa Rica
  • Pfizer Investigational Site
    Quito, Pichincha, Ecuador
  • Pfizer Investigational Site
    San Pedro Sula, Honduras
  • Pfizer Investigational Site
    Lima, L 31, Peru
  • Pfizer Investigational Site
    Lima, L27, Peru
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00553605
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 4, 2007
Start date
Jun 2007
Primary completion
Jun 2009
Completion
Jun 2009
Results posted
Jan 28, 2013
Last update
Jan 28, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Renal Colic→

Other studies from this sponsor

Pfizer

Start the discussion