Trial Outcomes & Findings for A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity (NCT NCT00712322)
NCT ID: NCT00712322
Last Updated: 2022-06-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline (Day 0) to Day 14
Results posted on
2022-06-09
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 milligrams/kilogram/day (mg/kg/day) dispensed per twice a day (BID) dosing, for 14 days.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
9
|
|
Overall Study
COMPLETED
|
12
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 milligrams/kilogram/day (mg/kg/day) dispensed per twice a day (BID) dosing, for 14 days.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Protocol deviation
|
0
|
1
|
0
|
Baseline Characteristics
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
Baseline characteristics by cohort
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=12 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=14 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
7.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
8.3 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: Per-protocol Population included all participants in the Safety Population who completed the study under treatment without major protocol deviation.
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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=10 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=11 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Maximum Bladder Capacity (MBC)
Baseline
|
180.21 milliliter (mL)
Standard Deviation 126.88
|
142.18 milliliter (mL)
Standard Deviation 104.49
|
165.89 milliliter (mL)
Standard Deviation 123.74
|
|
Change From Baseline in Mean Maximum Bladder Capacity (MBC)
Change From Baseline to Day 14
|
-36.58 milliliter (mL)
Standard Deviation 93.59
|
-14.64 milliliter (mL)
Standard Deviation 48.40
|
19.33 milliliter (mL)
Standard Deviation 76.12
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: 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.
Average volume of urine collected by catheterization at first contraction.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=11 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Volume at First Contraction
Baseline
|
85.09 mL
Standard Deviation 71.65
|
56.91 mL
Standard Deviation 64.04
|
63.94 mL
Standard Deviation 51.38
|
|
Change From Baseline in Mean Volume at First Contraction
Change From Baseline to Day 14
|
-2.17 mL
Standard Deviation 62.79
|
14.00 mL
Standard Deviation 86.43
|
22.13 mL
Standard Deviation 85.53
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: 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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=11 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Detrusor Pressure at First Contraction
Baseline
|
32.71 cm H2O
Standard Deviation 43.35
|
16.36 cm H2O
Standard Deviation 10.62
|
23.56 cm H2O
Standard Deviation 19.25
|
|
Change From Baseline in Detrusor Pressure at First Contraction
Change From Baseline to Day 14
|
-0.30 cm H2O
Standard Deviation 13.85
|
0.36 cm H2O
Standard Deviation 17.63
|
0.38 cm H2O
Standard Deviation 16.86
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: 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.
Average volume of urine collected by catheterization at first detectable leakage.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=10 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=5 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Volume at First Detectable Leakage
Baseline
|
151.25 mL
Standard Deviation 93.37
|
107.50 mL
Standard Deviation 117.50
|
113.70 mL
Standard Deviation 70.26
|
|
Change From Baseline in Mean Volume at First Detectable Leakage
Change From Baseline to Day 14
|
26.40 mL
Standard Deviation 48.37
|
-29.50 mL
Standard Deviation 67.40
|
-31.40 mL
Standard Deviation 96.26
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: 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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=10 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=11 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Change from Baseline to Day 14 at 30 cm H2O
|
-9.09 mL
Standard Deviation 58.70
|
-55.67 mL
Standard Deviation 101.26
|
19.40 mL
Standard Deviation 94.69
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Baseline at 10 cm H2O
|
58.58 mL
Standard Deviation 48.60
|
59.55 mL
Standard Deviation 49.98
|
83.71 mL
Standard Deviation 89.32
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Change from Baseline to Day 14 at 10 cm H2O
|
13.48 mL
Standard Deviation 94.96
|
0.27 mL
Standard Deviation 46.06
|
23.14 mL
Standard Deviation 91.69
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Baseline at 20 cm H2O
|
85.30 mL
Standard Deviation 73.75
|
83.00 mL
Standard Deviation 69.81
|
106.60 mL
Standard Deviation 66.77
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Change from Baseline to Day 14 at 20 cm H2O
|
-14.28 mL
Standard Deviation 65.95
|
-3.11 mL
Standard Deviation 48.41
|
-14.80 mL
Standard Deviation 71.48
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Baseline at 30 cm H2O
|
121.81 mL
Standard Deviation 84.56
|
118.17 mL
Standard Deviation 111.80
|
136.00 mL
Standard Deviation 98.77
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Baseline at 40 cm H2O
|
130.02 mL
Standard Deviation 92.57
|
137.50 mL
Standard Deviation 126.04
|
116.67 mL
Standard Deviation 90.64
|
|
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Change from Baseline to Day 14 at 40 cm H2O
|
-42.30 mL
Standard Deviation 56.14
|
-55.17 mL
Standard Deviation 106.36
|
-89.67 mL
Standard Deviation 91.72
|
SECONDARY outcome
Timeframe: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14Population: 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.
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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Catheterization Volume
Baseline
|
93.57 mL
Standard Deviation 64.18
|
65.98 mL
Standard Deviation 56.32
|
115.18 mL
Standard Deviation 71.64
|
|
Change From Baseline in Mean Catheterization Volume
Change From Baseline to Day 14
|
14.36 mL
Standard Deviation 44.68
|
5.36 mL
Standard Deviation 24.17
|
-5.50 mL
Standard Deviation 30.03
|
SECONDARY outcome
Timeframe: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14Population: 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.
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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=7 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Total Pad Weight In-between Catheterizations
Baseline
|
1428.157 milligram (mg)
Standard Deviation 687.549
|
764.250 milligram (mg)
Standard Deviation 469.197
|
690.875 milligram (mg)
Standard Deviation 452.234
|
|
Change From Baseline in Total Pad Weight In-between Catheterizations
Change From Baseline to Day 14
|
-274.786 milligram (mg)
Standard Deviation 416.441
|
289.000 milligram (mg)
Standard Deviation 440.619
|
38.125 milligram (mg)
Standard Deviation 354.528
|
SECONDARY outcome
Timeframe: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14Population: 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.
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.
Outcome measures
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=9 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=8 Participants
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Mean Catheterization Volume at First Awakening
Baseline
|
99.67 mL
Standard Deviation 61.14
|
107.44 mL
Standard Deviation 104.58
|
129.06 mL
Standard Deviation 69.40
|
|
Change From Baseline in Mean Catheterization Volume at First Awakening
Change From Baseline to Day 14
|
47.94 mL
Standard Deviation 53.79
|
23.69 mL
Standard Deviation 128.66
|
-7.75 mL
Standard Deviation 51.49
|
Adverse Events
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=12 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=14 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=9 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
11.1%
1/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
Other adverse events
| Measure |
Cohort 1 (Darifenacin 0.030 mg/kg/Day)
n=12 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 2 (Darifenacin 0.0625 mg/kg/Day)
n=14 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.
|
Cohort 3 (Darifenacin 0.125 mg/kg/Day)
n=9 participants at risk
Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
14.3%
2/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
22.2%
2/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
11.1%
1/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Investigations
Body temperature increased
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Investigations
Cardiac murmur
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
11.1%
1/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
11.1%
1/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
7.1%
1/14 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
0.00%
0/9 • From first dose of study drug to 30 days after the last dose of study drug (Up to 55 days)
Safety Population included all participants in the Full Analysis Set who took at least 1 dose of darifenacin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER