A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Urologic Diseases Clinical Trial

— Symphony  

Official title:

A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340027
• Other study ID #: 178-CL-100
• Secondary ID: 2010-020601-32
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2011
• Est. completion date: June 28, 2012

Study information

• Verified date: December 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1307
• Est. completion date: June 28, 2012
• Est. primary completion date: June 28, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria at Visit 1/Screening:

• Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m^2 and a total body weight between 50 and 95 kg;

• Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;

• Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.

• Inclusion Criteria at Visit 3/Baseline:

• Subject has experienced frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);

• Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.

Exclusion Criteria:

• Exclusion Criteria at Visit 1/Screening:

• Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;

• Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.

• Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.

• Subject has significant post-void residual (PVR) volume (> 150 mL);

• Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test);

• Subject has a neurological cause for detrusor overactivity;

• Subject has an indwelling catheter or practices intermittent self-catheterization;

• Subject has diabetic neuropathy;

• Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;

• Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);

• Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;

• Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;

• Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;

• Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);

• Subject is using medications intended to treat OAB or prohibited medications.

• Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;

• Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease);

• Subject has severe hypertension which is defined as a sitting average systolic blood pressure = 180 mmHg and/or an average diastolic blood pressure = 110 mmHg;

• Exclusion Criteria at Visit 2/Placebo Run-In:

• Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days;

• Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;

• Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);

• Subject has serum creatinine > 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN), gamma-glutamyltransferase (?-GT) > 3x ULN, or total bilirubin > 2x ULN, as assessed in Screening samples;

• Exclusion Criteria at Visit 3/Baseline:

• Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period;

• Subject has severe hypertension which is defined as a sitting average systolic blood pressure = 180 mmHg and/or an average diastolic blood pressure = 110 mmHg.

Related Conditions & MeSH terms

• Signs and Symptoms
• Urinary Bladder Diseases
• Urinary Bladder, Overactive
• Urologic Diseases
• Urological Manifestations

Intervention

Drug:
• Mirabegron
oral
• Solifenacin succinate
oral
• Placebo
oral

Locations

Country	Name	City	State
Belarus	BY37101	Minsk
Belarus	BY37102	Minsk
Belarus	BY37103	Minsk
Belarus	BY37104	Vitebsk
Belgium	BE32102	Brussels
Belgium	BE32104	Edegem
Belgium	BE32103	Gent
Belgium	BE32101	Leuven
Czechia	CZ42005	Bohumín
Czechia	CZ42003	Hradec Kralove
Czechia	CZ42011	Ostrava
Czechia	CZ42006	Plzen
Czechia	CZ42001	Prague
Czechia	CZ42009	Prague
Czechia	CZ42007	Prague 4
Czechia	CZ42010	Roudnice nad Labem
Czechia	CZ42012	Sternberk
Czechia	CZ42002	Uherske Hradiste
Denmark	DK45101	Aarhus N
Denmark	DK45102	Herlev
Denmark	DK45104	Holstebro
Finland	FI35803	Helsinki
Finland	FI35804	Kouvola
Finland	FI35801	Oulu
Finland	FI35802	Tampere
France	FR33104	Colmar Cedex
France	FR33108	Dijon
France	FR33103	Orleans
France	FR33111	Paris Cedex 13
France	FR33112	Paris cedex 20
France	FR33106	Toulouse
France	FR33110	Tours
Germany	DE49109	Bad Ems
Germany	DE49103	Göttingen
Germany	DE49117	Hagenow
Germany	DE49105	Hettstedt
Germany	DE49108	Leipzig
Germany	DE49110	Neustadt I. Sachsen
Germany	DE49118	Reutlingen
Germany	DE49101	Rostock
Germany	DE49111	Sangerhausen
Germany	DE49104	Wismar
Hungary	HU36108	Csongrád
Hungary	HU36101	Gyor
Hungary	HU36106	Körmend
Hungary	HU36110	Miskolc
Hungary	HU36104	Sopron
Hungary	HU36103	Szekszárd
Hungary	HU36107	Tatabánya
Italy	IT39103	Avellino
Italy	IT39101	Catanzaro
Italy	IT39105	Florence
Italy	IT39102	Treviglio (BG)
Netherlands	NL31104	Amsterdam
Netherlands	NL31106	Maastricht
Netherlands	NL31102	Sneek
Netherlands	NL31101	Winterswijk
Norway	NO47104	Elverum
Norway	NO47102	Hamar
Poland	PL48107	Krakow
Poland	PL48103	Lodz
Poland	PL48108	Lublin
Poland	PL48106	Piaseczno
Poland	PL48104	Pulawy
Poland	PL48101	Warsaw
Poland	PL48105	Warsaw
Poland	PL48112	Wiecbork
Poland	PL48111	Wroclaw
Portugal	PT35102	Coimbra
Portugal	PT35105	Coimbra
Portugal	PT35104	Lisbon
Portugal	PT35107	Lisbon
Portugal	PT35101	Porto
Portugal	PT35110	Porto
Portugal	PT35106	Tomar
Romania	RO40106	Brasov
Romania	RO40102	Bucharest
Romania	RO40103	Bucharest
Romania	RO40104	Bucharest
Romania	RO40108	Bucharest
Romania	RO40101	Craiova
Romania	RO40105	Craiova
Romania	RO40107	Sibiu
Russian Federation	RU70112	Kazan
Russian Federation	RU70108	Moscow
Russian Federation	RU70110	Moscow
Russian Federation	RU70101	Saint Petersburg
Russian Federation	RU70102	Saint Petersburg
Russian Federation	RU70103	Saint Petersburg
Russian Federation	RU70107	Saint Petersburg
Russian Federation	RU70106	St. Petersburg
Russian Federation	RU70109	St. Petersburg
Russian Federation	RU70113	Ufa
Slovakia	SK42109	Banska Bystrica
Slovakia	SK42112	Bratislava
Slovakia	SK42107	Kosice
Slovakia	SK42113	Malacky
Slovakia	SK42104	Nitra
Slovakia	SK42105	Pieštany
Slovakia	SK42106	Piestany
Slovakia	SK42102	Presov
Slovakia	SK42108	Trencin
Slovakia	SK42101	Trencín
Slovakia	SK42103	Zilina
Spain	ES34101	Madrid
Spain	ES34102	Madrid
Spain	ES34103	Madrid
Spain	ES34109	Madrid
Spain	ES34105	Pamplona
Spain	ES34104	San Juan de Alicante
Spain	ES34107	Sevilla
Sweden	SE46101	Gothenburg
Sweden	SE46103	Karlshamn
Sweden	SE46104	Malmo
Sweden	SE46102	Stockholm
Sweden	SE46105	Tanumshede
Ukraine	UA38104	Dnepropetrovsk
Ukraine	UA38102	Donetsk
Ukraine	UA38111	Donetsk
Ukraine	UA38106	Kiev
Ukraine	UA38109	Kiev
Ukraine	UA38107	Lviv
Ukraine	UA38101	Odessa
Ukraine	UA38103	Zaporizhzhya
United Kingdom	GB44103	Bristol
United Kingdom	GB44108	Cambridge
United Kingdom	GB44106	Garston
United Kingdom	GB44111	Glasgow
United Kingdom	GB44104	Nantwich
United Kingdom	GB44110	Northwood
United Kingdom	GB44107	Plymouth
United Kingdom	GB44101	Reading
United Kingdom	GB44105	Sandbach

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Belarus,  Belgium,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition	The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.	Baseline and Week 12
Secondary	Change From Baseline to Each Visit in Mean Volume Voided Per Micturition	The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours	The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Percentage of Participants With a Micturition Response	A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours	The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Percentage of Participants With Zero Incontinence Episodes Post-baseline	The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.	Weeks 2, 4, 8 and 12
Secondary	Percentage of Participants With 50% Reduction in Incontinence Episodes	The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours	The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Level of Urgency	Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours	The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours	Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.	Baseline and Weeks 2, 4, 8 and 12
Secondary	Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.	Baseline and Week 12
Secondary	Percentage of Participants With Improvement in PPBC	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.	Baseline and Week 12
Secondary	Percentage of Participants With Major Improvement in PPBC	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.	Baseline and Week 12
Secondary	Percentage of Participants With Deterioration in PPBC	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)	Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.	Baseline and Week 12
Secondary	Percentage of Participants With a Symptom Bother Response	Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score	Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.	Baseline and Week 12
Secondary	Percentage of Participants With a Health-related Quality of Life Total Score Response	Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.	Baseline and Week 12
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed.; In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.	Baseline and Week 12
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.; In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.	Baseline and Week 12
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score	The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.; In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.	Baseline and Week 12
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.	Baseline and Week 12
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)	The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)	This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)	The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.	Baseline and Week 12

External Links

•   Link to results on the Astellas Clinical Study Results website