Pain
Conditions
Keywords
Renal Colic Pain Urinary Tract 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.
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Intensity Difference at 30 Minutes (mPID30min) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-specific Pain Intensity (PI) VAS Score | 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 | 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) | 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) | 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. |
| Mean Pain Intensity Difference at 120 Min (mPID120min) | 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. |
| Patient's Global Evaluation of Study Medication | 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 | 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) | 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. |
| Number of Participants With Response in Pain Intensity | 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. |
Countries
Brazil, Chile, Costa Rica, Ecuador, Honduras, Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parecoxib Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes. | 174 |
| Ketoprofen Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes. | 164 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet entrance criteria | 1 | 3 |
| Overall Study | Did not receive full dose | 1 | 0 |
| Overall Study | Randomized but not treated | 2 | 0 |
Baseline characteristics
| Characteristic | Parecoxib | Total | Ketoprofen |
|---|---|---|---|
| Age, Customized 18 to 44 years | 131 participants | 240 participants | 109 participants |
| Age, Customized 45 to 64 years | 41 participants | 95 participants | 54 participants |
| Age, Customized Greater than or equal to (>=) 65 years | 1 participants | 2 participants | 1 participants |
| Age, Customized Less than (<) 18 years | 1 participants | 1 participants | 0 participants |
| Sex: Female, Male Female | 64 Participants | 125 Participants | 61 Participants |
| Sex: Female, Male Male | 110 Participants | 213 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 174 | 55 / 164 |
| serious Total, serious adverse events | 9 / 174 | 8 / 164 |
Outcome results
Primary
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
Population: Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib | Mean Pain Intensity Difference at 30 Minutes (mPID30min) | 34.147 mm | Standard Error 3.35 |
| Ketoprofen | Mean Pain Intensity Difference at 30 Minutes (mPID30min) | 35.266 mm | Standard Error 3.46 |
Comparison: LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.95% CI: [-6.53, 4.3]
Secondary
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
Population: Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib | Mean Pain Intensity Difference at 120 Min (mPID120min) | 51.608 mm | Standard Error 2.02 |
| Ketoprofen | Mean Pain Intensity Difference at 120 Min (mPID120min) | 51.697 mm | Standard Error 2.05 |
Comparison: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.97295% CI: [-5.04, 4.86]ANCOVA
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 30: none (n= 171, 162) | 10 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 30: a little (n= 171, 162) | 21 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 30: some (n= 171, 162) | 35 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 30: a lot (n= 171, 162) | 74 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 30: complete (n= 171, 162) | 31 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 120: none (n= 146, 139) | 1 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 120: a little (n= 146, 139) | 0 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 120: some (n= 146, 139) | 16 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 120: a lot (n= 146, 139) | 40 participants |
| Parecoxib | Number of Participants With Pain Relief (PR) | Minute 120: complete (n= 146, 139) | 89 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 120: some (n= 146, 139) | 8 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 30: none (n= 171, 162) | 9 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 120: none (n= 146, 139) | 1 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 30: a little (n= 171, 162) | 19 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 120: complete (n= 146, 139) | 80 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 30: some (n= 171, 162) | 44 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 120: a little (n= 146, 139) | 4 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 30: a lot (n= 171, 162) | 65 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 120: a lot (n= 146, 139) | 46 participants |
| Ketoprofen | Number of Participants With Pain Relief (PR) | Minute 30: complete (n= 171, 162) | 25 participants |
Comparison: Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.3982Cochran-Mantel-Haenszel
Comparison: Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.5552Cochran-Mantel-Haenszel
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parecoxib | Number of Participants With Response in Pain Intensity | 132 participants |
| Ketoprofen | Number of Participants With Response in Pain Intensity | 124 participants |
Comparison: p-value was based on logistic regression model with terms for treatment group and baseline as covariates.p-value: 0.978595% CI: [0.6, 1.69]Regression, Logistic
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parecoxib | Number of Participants With Use of Rescue Medication (RM) | 26 participants |
| Ketoprofen | Number of Participants With Use of Rescue Medication (RM) | 25 participants |
p-value: 0.9645Log Rank
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 30: poor | 12 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 30: fair | 21 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 30: good | 76 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 30: excellent | 63 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 120: poor | 8 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 120: fair | 16 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 120: good | 49 participants |
| Parecoxib | Patient's Global Evaluation of Study Medication | Minute 120: excellent | 98 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 120: excellent | 96 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 30: poor | 10 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 120: poor | 5 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 30: fair | 17 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 120: good | 46 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 30: good | 66 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 120: fair | 16 participants |
| Ketoprofen | Patient's Global Evaluation of Study Medication | Minute 30: excellent | 70 participants |
Comparison: Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.2482Cochran-Mantel-Haenszel
Comparison: Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.7659Cochran-Mantel-Haenszel
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 30: excellent | 70 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 120: poor | 8 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 120: fair | 14 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 120: good | 45 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 120: excellent | 104 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 30: poor | 11 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 30: fair | 22 participants |
| Parecoxib | Physician's Global Evaluation of Study Medication | Minute 30: good | 69 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 30: good | 63 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 30: excellent | 66 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 120: excellent | 95 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 120: poor | 8 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 30: fair | 23 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 120: fair | 15 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 30: poor | 11 participants |
| Ketoprofen | Physician's Global Evaluation of Study Medication | Minute 120: good | 45 participants |
Comparison: Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.9783Cochran-Mantel-Haenszel
Comparison: Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.p-value: 0.6847Cochran-Mantel-Haenszel
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'n' signifies participants who were evaluable at specific time points for each treatment arm respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 15 (n= 173, 164) | 26.72 mm | Standard Deviation 24.59 |
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 30 (n= 172, 162) | 42.89 mm | Standard Deviation 28.7 |
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 45 (n= 163, 156) | 54.37 mm | Standard Deviation 27.82 |
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 60 (n= 156, 152) | 61.35 mm | Standard Deviation 25.44 |
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 90 ( n= 151, 144) | 65.99 mm | Standard Deviation 22.88 |
| Parecoxib | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 120 (n= 147, 139) | 68.07 mm | Standard Deviation 21.14 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 90 ( n= 151, 144) | 64.33 mm | Standard Deviation 25.05 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 15 (n= 173, 164) | 26.04 mm | Standard Deviation 26.13 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 60 (n= 156, 152) | 59.34 mm | Standard Deviation 26.28 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 30 (n= 172, 162) | 43.22 mm | Standard Deviation 29.39 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 120 (n= 147, 139) | 68.51 mm | Standard Deviation 21.21 |
| Ketoprofen | Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120 | Minute 45 (n= 163, 156) | 53.55 mm | Standard Deviation 27.98 |
Comparison: Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.31495% CI: [-2.05, 6.37]ANCOVA
Comparison: Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.92695% CI: [-3.23, 3.55]ANCOVA
Comparison: Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.76895% CI: [-4.28, 5.79]ANCOVA
Comparison: Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.86695% CI: [-6.22, 5.24]ANCOVA
Comparison: Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.72995% CI: [-4.38, 6.26]ANCOVA
Comparison: Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.p-value: 0.2995% CI: [-2.24, 7.48]ANCOVA
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 30 (n= 172, 162) | 34.13 mm | Standard Deviation 28.57 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 60 (n= 156, 152) | 14.62 mm | Standard Deviation 21.25 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 15 (n= 173, 164) | 50.42 mm | Standard Deviation 26.92 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 90 (n= 151, 144) | 9.80 mm | Standard Deviation 17.16 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 45 (n= 163, 156) | 21.75 mm | Standard Deviation 24.89 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Minute 120 (n= 147, 139) | 7.68 mm | Standard Deviation 14.29 |
| Parecoxib | Time-specific Pain Intensity (PI) VAS Score | Baseline (n= 173, 164) | 77.14 mm | Standard Deviation 17.92 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 120 (n= 147, 139) | 8.02 mm | Standard Deviation 15.26 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Baseline (n= 173, 164) | 76.99 mm | Standard Deviation 18.26 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 15 (n= 173, 164) | 50.95 mm | Standard Deviation 24.65 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 30 (n= 172, 162) | 33.65 mm | Standard Deviation 26.64 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 45 (n= 163, 156) | 23.15 mm | Standard Deviation 24.93 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 60 (n= 156, 152) | 17.53 mm | Standard Deviation 23.17 |
| Ketoprofen | Time-specific Pain Intensity (PI) VAS Score | Minute 90 (n= 151, 144) | 12.27 mm | Standard Deviation 20.22 |
Secondary
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
Population: mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib | Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min) | 362.42 units on a scale | Standard Error 10.65 |
| Ketoprofen | Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min) | 352.29 units on a scale | Standard Error 10.85 |
Comparison: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.p-value: 0.45195% CI: [-16.3, 36.54]ANCOVA