| Primary | Change From Baseline in Mean Maximum Bladder Capacity (MBC) | MBC was defined as the volume of urine at which significant urinary leakage (i.e. leakage that prevents further volume increase) or significant discomfort/pain occurs, or a detrusor pressure at 40 centimeter (cm) H2O was reached. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. | Posted | | Mean | Standard Deviation | milliliter (mL) | | Baseline (Day 0) to Day 14 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. | | OG002 | Cohort 3 (Darifenacin 0.125 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG000180.21± 126.88
- OG001142.18± 104.49
- OG002165.89± 123.74
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| | Change From Baseline to Day 14 |
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| Secondary | Change From Baseline in Mean Volume at First Contraction | Average volume of urine collected by catheterization at first contraction. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | mL | | Baseline (Day 0) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. | | OG002 | Cohort 3 (Darifenacin 0.125 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Detrusor Pressure at First Contraction | | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | cm H2O | | Baseline (Day 0) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. | | OG002 | Cohort 3 (Darifenacin 0.125 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Mean Volume at First Detectable Leakage | Average volume of urine collected by catheterization at first detectable leakage. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | mL | | Baseline (Day 0) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. | | OG002 | Cohort 3 (Darifenacin 0.125 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure | | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | mL | | Baseline (Day 0) to Day 14 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. | | OG002 | Cohort 3 (Darifenacin 0.125 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Mean Catheterization Volume | Average volume of urine was collected by catheterization and was recorded in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | mL | | Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Total Pad Weight In-between Catheterizations | Urodynamic test was used to assess the total pad weight in-between catheterizations. The change in total pad weight in-between catheterizations was recorded in the bladder diary. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | milligram (mg) | | Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. |
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| Secondary | Change From Baseline in Mean Catheterization Volume at First Awakening | The change in urine volume at first awakening catherization was recorded by the participant in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement. | Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation. Number analyzed is the number of participants with available data at the given time point. | Posted | | Mean | Standard Deviation | mL | | Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14 | | | | ID | Title | Description |
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| OG000 | Cohort 1 (Darifenacin 0.030 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days. | | OG001 | Cohort 2 (Darifenacin 0.0625 mg/kg/Day) | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. |
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