THIS IS A MULTINATIONAL STUDY COMPARING THE EFFICACY AND SAFETY OF TWO MEDICINES, SOLIFENACIN SUCCINATE AND MIRABEGRON TAKEN TOGETHER, OR SEPARATELY, OR A MOCK TREATMENT (PLACEBO) IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER.”
- Conditions
- -N31N31
- Registration Number
- PER-091-13
- Lead Sponsor
- Astellas Pharma Europe B.V,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 14
At Screening (Visit 1):
1. Subject is male or female and at least 18 years of age.
2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
3. Female subject must be either:
•Of non childbearing potential:
opost-menopausal (defined as at least 1 year without menses in the absence of other plausible etiology) prior to Screening, or
odocumented surgically sterile (at least 1 month prior to Screening) or status post hysterectomy
•Or, if of childbearing potential:
omust have a negative urine pregnancy test at Screening, and
omust use a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS. Birth control must be practiced from Screening and throughout the study period and for 28 days after the final study drug administration.
4. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
5. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
6. Male subject and their female spouse/partners who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from Screening and continue throughout the study period and for 90 days after the final study drug administration.
7. Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.
8. Subject is willing and able to complete the micturition diary and questionnaires correctly 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.
9. Subject has symptoms of wet” OAB (urinary frequency and urgency with incontinence) for at least 3 months.
10. Subject agrees not to participate in another interventional study while on treatment.
At Randomization (Visit 2):
11. Subject continues to meet all inclusion criteria of Visit 1.
12. Subject has a micturition frequency of on average at least 8 times per 24-hour period during the 7-day micturition diary period (excluding incontinence episodes).
13. Subject has experienced at least 3 incontinence episodes during the 7-day micturition diary period.
14. Subject has experienced at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.
Waivers to the inclusion criteria will NOT be allowed
At Screening (Visit 1):
1. In the opinion of the investigator the subject has clinically significant bladder outflow obstruction at risk of urinary retention.
2. Subject has significant PVR volume (> 150 mL).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator.
4. Subject has a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy or systemic or central neurological disease such as multiple sclerosis and Parkinson’s disease).
5. Subject has an indwelling catheter or practices intermittent self-catheterization.
6. Subject has chronic inflammation such as bladder pain syndrome / interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
7. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
8. Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn’s Disease, toxic megacolon, myasthenia gravis or any contraindications against the use of anticholinergics.
9. Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior
to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, stroke and severe cardiac failure (NYHA class ≥ III) (Appendix 4).
10. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
11. Subject has clinically significant abnormal 12-lead ECG.
12. 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.
13. Subject has moderate to severe hepatic impairment (Child-Pugh class B or C) (Appendix 5).
14. Subject has severe renal impairment defined as eGFR<30 mL/min/1.73 m2.
15. Subject has a current or previous malignant disease of the pelvis. Subjects with a history of (nonpelvic) cancer are considered eligible if the subject has undergone therapy and the subject has been considered disease free for at least 5 years. Subjects with completely excised basal cell or squamous cell carcinoma of the skin and completely excised cervical cancer in situ are also considered eligible.
16. Subject is receiving current non-drug treatment for OAB including electrostimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening).
17. Subject is using medications intended to treat OAB or other prohibited medications. Subject is excluded if using restricted medications under conditions different to those specified in section Concomitant Medication (Section 5.1.3.2).
18. Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients.
19. Subjects with current or history of alcohol and/or drug abuse.
20. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
21. Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to Screening. If local regulations stipulate a longer period, such local regulations should take
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method