| 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. | 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. | Posted | | Least Squares Mean | Standard Error | mm | | Minute 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00034.147± 3.35
- OG00135.266± 3.46
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | | | | | Least-squares (LS) mean difference | -1.12 | Standard Error of the Mean | 2.75 | 2-Sided | 95 | -6.53 | 4.30 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm. | |
|
| 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. | 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. | Posted | | Least Squares Mean | Standard Error | mm | | Minute 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline, Minute 15, 30, 45, 60, 90, 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline, Minute 15, 30, 45, 60, 90, 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline through Minute 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | | participants | | Minute 30, 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | | participants | | Minute 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | | participants | | Minute 30, 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | | participants | | Minute 30, 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. | Posted | | Number | | participants | | Up to Minute 120 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |