CognitionPhase 4SENIORNCT01126424

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

A Phase 4 study testing Solifenacin and Oxybutynin in people with Cognition, run by Astellas Pharma Inc at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability. Read more about this study

Who is it for?: Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for: Cognition
What is being tested?: Solifenacin and Oxybutynin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 3 sitesUnited Kingdom
Study dates: Apr 2010to Dec 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

The subject has mild cognitive impairment as determined by mini-mental state examination (MMSE) ≥ grade 24
The subject conforms to the Stockholm criteria for mild cognitive impairment as assessed by the investigator
The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive
The subject is available to complete the study

Who cannot join

The subject has moderate or severe cognitive impairment as determined by MMSE criteria at screening, ≤ grade 23
The subject has depression as determined by Geriatric Depression Scale (GDS) short form ≥ 5 at screening
The subject has a history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
The subject is undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. Ketoconazole
The subject has uncontrolled diabetes mellitus
The subject has a positive pre-study hepatitis B surface antigen, hepatitis C antibody or HIV result at time of screening

Show all 22Show fewer

The subject has a history of drug and / or alcohol abuse at time of screening
The subject has an average weekly alcohol intake of greater than 21 units (male) or 14 units (female) within ≤ 3 months prior to screening (1 unit is 270cc of beer, 40cc of spirits or 125cc of wine)
The subject has a history of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within ≤ 3 months prior to screening
The subject has a history of known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form
The subject has taken any unstable doses of prescribed medication within ≤ 1 month prior to screening or over-the-counter medicine (including vitamins and herbal remedies) within 48 hours prior to the first study day, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety
The subject is currently dosing with medication(s) intended to treat overactive bladder symptoms or has history of non-drug treatment intended to treat overactive bladder symptoms within ≤ 3 months prior to screening
The subject has any clinically significant abnormality following Investigator review of the physical examination
The subject has any clinically significant abnormality following the Investigator's review of the ECG
The subject has mobility impairment that precludes the assessment of postural stability
The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit (dBP > 90mmHg, sBP > 160mmHg or HR < 40bpm or > 100bpm)
The subject has any clinically significant abnormality following Investigator's review of the biochemistry \& hematology results which, in the opinion of the Investigator, contraindicates their participation
The subject has donated blood or plasma within ≤ 3 months prior to screening or more than 500ml or 1 unit of blood or plasma within ≤ 6 months prior to screening
The subject, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol
The subject has participated in any clinical study within ≤ 3 months prior to screening
The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, contraindicates their participation
The subject is an employee of Astellas Pharma, Cognitive Drug Research, and any other third party related to the study site

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

Study site
Blackpool, Lancashire, FY2 0JH
Study site
Bradford, Yorkshire, BD3 0DQ
Study site
Manchester, Lancashire, M50 2GY

Other trials in United Kingdom

About this study

Official title: A Study to Compare the Cognitive Effect of Solifenacin 5mg Once-daily and Oxybutynin 5mg Twice-daily After Chronic Dosing Versus Placebo in Subjects 75 Years and Over With Mild Cognitive Impairment - A Double-blind, Randomized, Multi-center Study

The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability.

Read the detailed description

All subjects will receive each intervention during the course of the study. Subjects will complete a 21-day washout period between treatment periods and following last treatment period.

Conditions: Cognition
Being tested: Solifenacin, Oxybutynin, Placebo
Keywords: Anti-muscarinics, Anti-cholinergics, Cognition, Solifenacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SolifenacinDrug
Also called YM905
tablet
OxybutyninDrug
capsule
PlaceboDrug
tablet

Study groups in NCT01126424
Study group	Role	What they receive
Solifenacin	Experimental	Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day. Receives: Drug: Solifenacin
Oxybutynin	Active comparator	Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form. Receives: Drug: Oxybutynin
Placebo	Placebo comparator	Participants received 21 days of treatment with placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Cognitive Function Composite Score - Power of Attention
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.
Measured: 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.
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention
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.
Measured: 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.
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory
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.
Measured: 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.
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory
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.
Measured: 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.
Change From Baseline in Cognitive Function Composite Score - Speed of Memory
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.
Measured: 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.

Secondary outcomes (1)

Change From Baseline in Postural Stability Test
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Dec 2010

First posted19 May 2010 (estimated)
Study startApr 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CognitionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01126424
Sponsor's protocol ID: 905-EC-008
Other IDs: 2008-005966-29, 2008
Acronym: SENIOR
Status last verified: Sep 2012
First submitted: 29 Apr 2010
Last updated: 15 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wright BM. A simple mechanical ataxia-meter. J Physiol. 1971 Oct;218 Suppl:27P-28P. No abstract available.
PubMed 5130616
Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.
PubMed 23332882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Cognitive Effect of Solifenacin 5mg Once-daily and Oxybutynin 5mg Twice-daily After Chronic Dosing Versus Placebo in Subjects 75 Years and Over With Mild Cognitive Impairment - A Double-blind, Randomized, Multi-center Study
ClinicalTrials.gov ID: NCT01126424
Acronym / sponsor ID: SENIOR / 905-EC-008
Conditions: Cognition
Keywords: Anti-muscarinics, Anti-cholinergics, Cognition, Solifenacin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 May 2010 (estimated)
Results: Posted 15 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability.

Detailed description

All subjects will receive each intervention during the course of the study. Subjects will complete a 21-day washout period between treatment periods and following last treatment period.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Solifenacin	Experimental	Drug: SolifenacinParticipants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
Oxybutynin	Active comparator	Drug: OxybutyninParticipants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
Placebo	Placebo comparator	Drug: PlaceboParticipants received 21 days of treatment with placebo.

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

The subject has mild cognitive impairment as determined by mini-mental state examination (MMSE) ≥ grade 24
The subject conforms to the Stockholm criteria for mild cognitive impairment as assessed by the investigator
The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive
The subject is available to complete the study

Key exclusion criteria (22 listed)

The subject has moderate or severe cognitive impairment as determined by MMSE criteria at screening, ≤ grade 23
The subject has depression as determined by Geriatric Depression Scale (GDS) short form ≥ 5 at screening
The subject has a history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
The subject is undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. Ketoconazole
The subject has uncontrolled diabetes mellitus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SolifenacinAlso: YM905tablet	Drug	Solifenacin
Oxybutynincapsule	Drug	Oxybutynin
Placebotablet	Drug	Placebo

Primary outcome

Change From Baseline in Cognitive Function Composite Score - Power of Attention
Time frame: 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.
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.
Change From Baseline in Cognitive Function Composite Score - Continuity of Attention
Time frame: 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.
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.
Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory
Time frame: 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.
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.
Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory
Time frame: 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.
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.
Change From Baseline in Cognitive Function Composite Score - Speed of Memory
Time frame: 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.
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.

1 secondary outcome

Change From Baseline in Postural Stability Test
Time frame: 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 and safety

Results posted to the registry on 15 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solifenacin / Oxybutynin / Placebo	3	3
Solifenacin / Placebo / Oxybutynin	4	4
Oxybutynin / Placebo / Solifenacin	5	4
Oxybutynin / Solifenacin / Placebo	6	3
Placebo / Solifenacin / Oxybutynin	4	2
Placebo / Oxybutynin / Solifenacin	4	4

Primary outcome: Change From Baseline in Cognitive Function Composite Score - Power of Attention

Time frame: 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.. Mean (Standard Deviation). Unit: msec

Measure	Solifenacin n = 22	Oxybutynin n = 20	Placebo n = 22
Baseline at 2 hours [Oxybutynin Tmax]	1413.67 (180.242)	1423.38 (186.163)	1401.21 (177.194)
Change from Baseline at 2 hours	-5.86 (71.371)	17.81 (92.340)	1.99 (54.145)
Baseline at 6 hours [Solifenacin Tmax]	1421.80 (191.303)	1405.41 (182.929)	1393.98 (189.128)
Change from Baseline at 6 hours	-14.80 (87.918)	-0.74 (62.650)	11.77 (93.655)

Solifenacin vs Placebo: Least Square Mean Difference: -20.986 (95% CI -68.580 to 26.607), p = 0.3771, ANCOVA
Oxybutynin vs Placebo: Least Square Mean Difference: 17.508 (95% CI -28.854 to 63.870), p = 0.4487, ANCOVA

Population analysed: 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.

Primary outcome: Change From Baseline in Cognitive Function Composite Score - Continuity of Attention

Measure	Solifenacin n = 22	Oxybutynin n = 20	Placebo n = 22
Baseline at 2 hours [Oxybutynin Tmax]	91.591 (3.2462)	91.300 (2.5775)	91.364 (2.3409)
Change from Baseline at 2 hours	0.545 (2.0637)	0.150 (3.2653)	0.909 (2.6168)
Baseline at 6 hours [Solifenacin Tmax]	91.228 (2.0454)	91.901 (2.4040)	91.728 (3.6929)
Change from Baseline at 6 hours	-0.318 (2.7143)	0.100 (2.7121)	-0.045 (3.4566)

Solifenacin vs Placebo: Least Square Mean Difference: -0.507 (95% CI -2.293 to 1.279), p = 0.5684, ANCOVA
Oxybutynin vs Placebo: Least Square Mean Difference: -0.792 (95% CI -2.122 to 0.538), p = 0.2348, ANCOVA

Primary outcome: Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory

Measure	Solifenacin n = 22	Oxybutynin n = 20	Placebo n = 22
Baseline at 2 hours [Oxybutynin Tmax]	1.7921 (0.24313)	1.7251 (0.31582)	1.7087 (0.24215)
Change from Baseline at 2 hours	-0.0867 (0.39254)	-0.0043 (0.35428)	0.0492 (0.37776)
Baseline at 6 hours [Solifenacin Tmax]	1.6666 (0.35805)	1.6441 (0.34113)	1.7548 (0.35808)
Change from Baseline at 6 hours	0.0580 (0.46462)	0.0633 (0.46684)	0.0047 (0.41656)

Solifenacin vs Placebo: Least Square Mean Difference: -0.040 (95% CI -0.208 to 0.127), p = 0.6275, ANCOVA
Oxybutynin vs Placebo: Least Square Mean Difference: -0.046 (95% CI -0.194 to 0.103), p = 0.5361, ANCOVA

Primary outcome: Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory

Measure	Solifenacin n = 22	Oxybutynin n = 20	Placebo n = 22
Baseline at 2 hours [Oxybutynin Tmax]	111.893636 (48.525110)	107.666333 (55.168759)	110.000152 (51.736947)
Change from Baseline at 2 hours	-3.788636 (35.609118)	-0.917833 (28.198821)	0.531515 (42.576179)
Baseline at 6 hours [Solifenacin Tmax]	101.363485 (44.919411)	104.917167 (50.380503)	106.515000 (45.147568)
Change from Baseline at 6 hours	7.728182 (30.836915)	-3.502000 (48.822365)	1.589394 (35.687431)

Solifenacin vs Placebo: Least Square Mean Difference: 4.655 (95% CI -14.858 to 24.167), p = 0.6315, ANCOVA
Oxybutynin vs Placebo: Least Square Mean Difference: -1.457 (95% CI -18.976 to 16.062), p = 0.8670, ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solifenacin	1 of 23 (4.3%)	5 of 23 (21.7%)	Not reported
Oxybutynin	1 of 25 (4%)	14 of 25 (56%)	Not reported
Placebo	0 of 22 (0%)	6 of 22 (27.3%)	Not reported

Limitations and caveats (from the sponsor): Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 5130616Wright BM. A simple mechanical ataxia-meter. J Physiol. 1971 Oct;218 Suppl:27P-28P. No abstract available.
Derived from this study: PubMed 23332882Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.
Link to Prescribing InformationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Use Central Contact study director

Astellas Pharma Europe Ltd.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Solifenacin and Oxybutynin in people with Cognition, run by Astellas Pharma Inc at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cognitive Function Composite Score - Power of Attention (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126424, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.