Trial Outcomes & Findings for A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability (NCT NCT01126424)

NCT ID: NCT01126424

Last Updated: 2012-10-15

Results Overview

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.
• Results posted on: 2012-10-15

Participant Flow

Participant milestones

Measure	Solifenacin / Oxybutynin / Placebo Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.	Solifenacin / Placebo / Oxybutynin Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Oxybutynin / Placebo / Solifenacin Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.	Oxybutynin / Solifenacin / Placebo Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.	Placebo / Solifenacin / Oxybutynin Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Placebo / Oxybutynin / Solifenacin Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
Overall Study STARTED	3	4	5	6	4	4
Overall Study Safety Analysis Subset 1 (SAF 1)	3	4	4	4	4	4
Overall Study COMPLETED	3	4	4	3	2	4
Overall Study NOT COMPLETED	0	0	1	3	2	0

Reasons for withdrawal

Measure	Solifenacin / Oxybutynin / Placebo Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.	Solifenacin / Placebo / Oxybutynin Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Oxybutynin / Placebo / Solifenacin Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.	Oxybutynin / Solifenacin / Placebo Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.	Placebo / Solifenacin / Oxybutynin Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Placebo / Oxybutynin / Solifenacin Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
Overall Study Adverse Event	0	0	0	0	1	0
Overall Study Withdrawal by Subject	0	0	1	3	1	0

Baseline Characteristics

A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability

Baseline characteristics by cohort

Measure	Solifenacin / Oxybutynin / Placebo n=3 Participants Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.	Solifenacin / Placebo / Oxybutynin n=4 Participants Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Oxybutynin / Placebo / Solifenacin n=5 Participants Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.	Oxybutynin / Solifenacin / Placebo n=6 Participants Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.	Placebo / Solifenacin / Oxybutynin n=4 Participants Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.	Placebo / Oxybutynin / Solifenacin n=4 Participants Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.	Total n=26 Participants Total of all reporting groups
Age Continuous	79.7 years STANDARD_DEVIATION 3.8 • n=5 Participants	78.8 years STANDARD_DEVIATION 2.5 • n=7 Participants	80.2 years STANDARD_DEVIATION 4.4 • n=5 Participants	76.7 years STANDARD_DEVIATION 2.0 • n=4 Participants	79.3 years STANDARD_DEVIATION 2.9 • n=21 Participants	79.0 years STANDARD_DEVIATION 4.1 • n=10 Participants	78.8 years STANDARD_DEVIATION 3.2 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	12 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	14 Participants n=115 Participants
Race/Ethnicity, Customized White	3 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	4 participants n=21 Participants	4 participants n=10 Participants	26 participants n=115 Participants
Stockholm criteria for mild cognitive impairment Yes	3 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	4 participants n=21 Participants	4 participants n=10 Participants	26 participants n=115 Participants
Stockholm criteria for mild cognitive impairment No	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	0 participants n=115 Participants
Total Mini-Mental State Examination (MMSE) Score	27.7 scores on a scale STANDARD_DEVIATION 0.58 • n=5 Participants	28.3 scores on a scale STANDARD_DEVIATION 1.26 • n=7 Participants	28.0 scores on a scale STANDARD_DEVIATION 1.00 • n=5 Participants	27.3 scores on a scale STANDARD_DEVIATION 1.75 • n=4 Participants	26.5 scores on a scale STANDARD_DEVIATION 1.00 • n=21 Participants	27.3 scores on a scale STANDARD_DEVIATION 2.06 • n=10 Participants	27.5 scores on a scale STANDARD_DEVIATION 1.39 • n=115 Participants
Total Geriatric Depression Scale (GDS) Score	1.0 scores on a scale STANDARD_DEVIATION 1.73 • n=5 Participants	1.0 scores on a scale STANDARD_DEVIATION 0.82 • n=7 Participants	1.4 scores on a scale STANDARD_DEVIATION 1.67 • n=5 Participants	1.0 scores on a scale STANDARD_DEVIATION 0.63 • n=4 Participants	1.3 scores on a scale STANDARD_DEVIATION 0.96 • n=21 Participants	1.8 scores on a scale STANDARD_DEVIATION 1.26 • n=10 Participants	1.2 scores on a scale STANDARD_DEVIATION 1.11 • n=115 Participants

PRIMARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Cognitive Function Composite Score - Power of Attention Baseline at 2 hours [Oxybutynin Tmax]	1413.67 msec Standard Deviation 180.242	1423.38 msec Standard Deviation 186.163	1401.21 msec Standard Deviation 177.194
Change From Baseline in Cognitive Function Composite Score - Power of Attention Change from Baseline at 2 hours	-5.86 msec Standard Deviation 71.371	17.81 msec Standard Deviation 92.340	1.99 msec Standard Deviation 54.145
Change From Baseline in Cognitive Function Composite Score - Power of Attention Baseline at 6 hours [Solifenacin Tmax]	1421.80 msec Standard Deviation 191.303	1405.41 msec Standard Deviation 182.929	1393.98 msec Standard Deviation 189.128
Change From Baseline in Cognitive Function Composite Score - Power of Attention Change from Baseline at 6 hours	-14.80 msec Standard Deviation 87.918	-0.74 msec Standard Deviation 62.650	11.77 msec Standard Deviation 93.655

PRIMARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention Baseline at 2 hours [Oxybutynin Tmax]	91.591 Scores on a scale Standard Deviation 3.2462	91.300 Scores on a scale Standard Deviation 2.5775	91.364 Scores on a scale Standard Deviation 2.3409
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention Change from Baseline at 2 hours	0.545 Scores on a scale Standard Deviation 2.0637	0.150 Scores on a scale Standard Deviation 3.2653	0.909 Scores on a scale Standard Deviation 2.6168
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention Baseline at 6 hours [Solifenacin Tmax]	91.228 Scores on a scale Standard Deviation 2.0454	91.901 Scores on a scale Standard Deviation 2.4040	91.728 Scores on a scale Standard Deviation 3.6929
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention Change from Baseline at 6 hours	-0.318 Scores on a scale Standard Deviation 2.7143	0.100 Scores on a scale Standard Deviation 2.7121	-0.045 Scores on a scale Standard Deviation 3.4566

PRIMARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory Baseline at 2 hours [Oxybutynin Tmax]	1.7921 Scores on a scale Standard Deviation 0.24313	1.7251 Scores on a scale Standard Deviation 0.31582	1.7087 Scores on a scale Standard Deviation 0.24215
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory Change from Baseline at 2 hours	-0.0867 Scores on a scale Standard Deviation 0.39254	-0.0043 Scores on a scale Standard Deviation 0.35428	0.0492 Scores on a scale Standard Deviation 0.37776
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory Baseline at 6 hours [Solifenacin Tmax]	1.6666 Scores on a scale Standard Deviation 0.35805	1.6441 Scores on a scale Standard Deviation 0.34113	1.7548 Scores on a scale Standard Deviation 0.35808
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory Change from Baseline at 6 hours	0.0580 Scores on a scale Standard Deviation 0.46462	0.0633 Scores on a scale Standard Deviation 0.46684	0.0047 Scores on a scale Standard Deviation 0.41656

PRIMARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory Baseline at 2 hours [Oxybutynin Tmax]	111.893636 Scores on a scale Standard Deviation 48.525110	107.666333 Scores on a scale Standard Deviation 55.168759	110.000152 Scores on a scale Standard Deviation 51.736947
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory Change from Baseline at 2 hours	-3.788636 Scores on a scale Standard Deviation 35.609118	-0.917833 Scores on a scale Standard Deviation 28.198821	0.531515 Scores on a scale Standard Deviation 42.576179
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory Baseline at 6 hours [Solifenacin Tmax]	101.363485 Scores on a scale Standard Deviation 44.919411	104.917167 Scores on a scale Standard Deviation 50.380503	106.515000 Scores on a scale Standard Deviation 45.147568
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory Change from Baseline at 6 hours	7.728182 Scores on a scale Standard Deviation 30.836915	-3.502000 Scores on a scale Standard Deviation 48.822365	1.589394 Scores on a scale Standard Deviation 35.687431

PRIMARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Cognitive Function Composite Score - Speed of Memory Baseline at 2 hours [Oxybutynin Tmax]	4505.96 msec Standard Deviation 957.434	4545.75 msec Standard Deviation 789.173	4741.30 msec Standard Deviation 820.101
Change From Baseline in Cognitive Function Composite Score - Speed of Memory Change from Baseline at 2 hours	24.09 msec Standard Deviation 762.881	-11.56 msec Standard Deviation 571.131	-240.62 msec Standard Deviation 471.516
Change From Baseline in Cognitive Function Composite Score - Speed of Memory Baseline at 6 hours [Solifenacin Tmax]	4496.65 msec Standard Deviation 653.186	4606.51 msec Standard Deviation 846.669	4655.29 msec Standard Deviation 923.390
Change From Baseline in Cognitive Function Composite Score - Speed of Memory Change from Baseline at 6 hours	-149.79 msec Standard Deviation 494.835	-118.14 msec Standard Deviation 471.318	-126.04 msec Standard Deviation 728.870

SECONDARY outcome

Timeframe: Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.

Population: The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.

The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.

The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut.

Outcome measures

Measure	Solifenacin n=22 Participants Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=20 Participants Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 Participants Participants received 21 days of treatment with placebo.
Change From Baseline in Postural Stability Test Baseline at 2 hours [Oxybutynin Tmax]	37.7 1/3 degree of angle of sway Standard Deviation 23.35	36.2 1/3 degree of angle of sway Standard Deviation 20.05	37.5 1/3 degree of angle of sway Standard Deviation 20.04
Change From Baseline in Postural Stability Test Change from Baseline at 2 hours	5.2 1/3 degree of angle of sway Standard Deviation 9.65	2.7 1/3 degree of angle of sway Standard Deviation 17.04	0.4 1/3 degree of angle of sway Standard Deviation 16.81
Change From Baseline in Postural Stability Test Baseline at 6 hours [Solifenacin Tmax]	37.7 1/3 degree of angle of sway Standard Deviation 19.42	38.9 1/3 degree of angle of sway Standard Deviation 23.59	40.0 1/3 degree of angle of sway Standard Deviation 26.19
Change From Baseline in Postural Stability Test Change from Baseline at 6 hours	9.9 1/3 degree of angle of sway Standard Deviation 16.14	0.7 1/3 degree of angle of sway Standard Deviation 17.60	-0.1 1/3 degree of angle of sway Standard Deviation 10.64

Adverse Events

Solifenacin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Oxybutynin

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Solifenacin n=23 participants at risk Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=25 participants at risk Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 participants at risk Participants received 21 days of treatment with placebo.
Eye disorders Vitreous detachment	4.3% 1/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Gastrointestinal disorders Gastrointestinal disorders	0.00% 0/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	4.0% 1/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.

Other adverse events

Measure	Solifenacin n=23 participants at risk Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.	Oxybutynin n=25 participants at risk Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.	Placebo n=22 participants at risk Participants received 21 days of treatment with placebo.
Gastrointestinal disorders Dry mouth	17.4% 4/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	52.0% 13/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	9.1% 2/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	12.0% 3/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	4.0% 1/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	9.1% 2/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	8.0% 2/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Nervous system disorders Balance disorder	8.7% 2/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Renal and urinary disorders Micturition disorder	0.00% 0/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	9.1% 2/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	0.00% 0/25 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.	9.1% 2/22 • Treatment emergent adverse events were collected by treatment period from first administration of the study/comparative drug until within 7 days of taking the last dose. A treatment period consists of about 21 treatment days with a follow-up of either about 21 washout days prior to start of next treatment period or a follow-up of 7 days for the last treatment period.

Additional Information

Associate Medical Director Urology

Astellas Pharma Europe Ltd.

Email: clinicaltrials@us.astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may not publish trial data generated at their specific study site without prior written approval of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER