Study to investigate the effect and safety of ASP8302 in the treatment of subjects with an underactive bladder
- Conditions
- nderactive BladderMedDRA version: 21.1Level: LLTClassification code 10021635Term: Incomplete bladder emptyingSystem Organ Class: 100000004857MedDRA version: 21.0Level: LLTClassification code 10060695Term: Residual urineSystem Organ Class: 100000004857MedDRA version: 20.1Level: LLTClassification code 10005071Term: Bladder retentionSystem Organ Class: 100000004857MedDRA version: 20.0Level: LLTClassification code 10012549Term: Detrusor muscle weaknessSystem Organ Class: 100000004857MedDRA version: 21.1Level: LLTClassification code 10047863Term: Weakness detrusor muscleSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2017-003693-13-PL
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 163
At Study Entry – Screening (visit 1):
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
3. Subject is diagnosed with UAB, defined as a bothersome chronic incomplete bladder emptying:
• clinical condition is present for = 6 months before screening, and
• subject has a PVR = 75 mL (measured by ultrasound after uroflowmetry; V1_PVRUS1).
4. Subject on CIC should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC.
5. Female subject must either:
•Be of non-childbearing potential:
-Post-menopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
-Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
•Or, if of childbearing potential:
-Agrees not to try to become pregnant during the study and for 28 days after the final study drug administration
-Agrees to have a serum pregnancy test on all visits
-And have a negative serum pregnancy test at the screening visit
-And agrees to consistently use 1 form of highly effective birth control* starting at screening and throughout the study period and for 28 days after the final study drug administration.
6. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug administration.
7. Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
8. A sexually active male subject with female partner(s) of childbearing
potential
(including breastfeeding partner(s)) is eligible if he agrees to use a male
condom starting
at screening and continue throughout study treatment and for 90 days
after the final
study drug administration. If the male subject has not had a vasectomy
or is not sterile as
defined below, his female partner(s) is utilizing 1 form of highly
effective birth
control*starting at screening and will continue throughout study
treatment and for 90
days after the male subject receives the final study drug administration.
9. Male subject must not donate sperm starting at screening and
throughout the study period and for 90 days after the final study drug
administration.
10. Male subject with a pregnant partner(s) must agree to remain
abstinent or use a condom
for the duration of the pregnancy throughout the study period and for 28
days after the
final study drug administration.
*Highly effective forms of birth control include:
• Consistent and correct usage of established hormonal contraceptives that inhibit ovulation
• Established intrauterine device or intrauterine system
• Bilateral tubal occlusion
• Vasectomy (a vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used)
• Male is sterile due to a bilateral orchiectomy
• Sexual Abstinence is considered a highly effective method only if defined as refrai
At Study Entry – Screening (visit 1):
Related to lower urinary tract:
1. Subject has significant BOO:
•Clinically significant urethral stricture in the opinion of the investigator.
•Female subject has uterine prolapse = Grade 2 Shaw’s system (down to or outside the introitus), moderate or severe cystocele (reaches or protrudes outside the introitus).
•Male subject has a bladder outlet obstruction index (BOOI) = 40 on PFS (either performed on screening or within 12 months of the screening visit), or –if PFS is not available–a PV of > 40 mL (Europe) > 30 mL (Japan) on ultrasound (either performed on screening or within 6 months of the screening visit). Note: if PFS is available and PV is above the cut-off level, the subject is not to be excluded if BOOI is < 40.
• Other condition that in the opinion of the investigator constitutes significant BOO.
2. Urgency urinary incontinence clinically significant in the opinion of the investigator.
3. 1 or more bladder diverticuli clinically significant in the opinion of the investigator.
4.Vesico-ureteral/renal reflux clinically significant in the opinion of the investigator.
5. Urinary catheter in situ.
6. 1 of the following conditions as a primary cause for their UAB, or a condition that could potentially influence treatment outcome:
•Neurological lesion or condition, including cerebrovascular accident, spinal lumbar disc hernia, spinal cord injury, multiple sclerosis, Parkinson’s disease, Guillain–Barré syndrome, pudendal, hypogastric or pelvic nerve lesion. Diabetes mellitus is allowed if controlled with or without medical treatment.
•Increased pelvic floor muscle activity during voiding (e.g., dyssynergic striated sphincteric activity/striated sphincteric activity during voiding, Fowler syndrome and pelvic floor muscle spasm).
•Previous bladder surgery. Prior Benign Prostatic Obstruction surgery is allowed if performed more than 6 months prior to screening.
•Previous implant surgery for incontinence still in situ.
•Significant active urological pain syndrome
•Previous pelvic radiation therapy
7. Dependence on use of a manual assistance method intended to improve bladder emptying.
Related to (previous or current) treatment and/or study drug:
8. 1 or more of the following non-medication therapies:
•Electrostimulation therapy.
•Intravesical or injection based treatment.
•An ongoing bladder training program and/or pelvic floor muscle exercises, which started within 6 weeks prior to visit 1.
•Muscle-derived stem cell injection in the bladder or urethra or bladder transplantation at any time prior to screening.
10. Known or suspected hypersensitivity to ASP8302 or any of the inactive ingredients.
11. Inflammatory bowel disease or clinically significant diarrhea.
12. Subject is known to be immunocompromised due to conditions such as human immunodeficiency virus/acquired immune deficiency syndrome or hepatitis C.
13. Diagnosed with clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1.
14.Diagnosed with clinically significant asthma, chronic bronchitis and/or chronic obstructive pulmonary disease.
15. Mean Fridericia corrected QT interval (QTcF) > 430 ms for males or > 450 ms for females, a pre-existing long QT syndrome or hypokalemia.
16. Clinically significant abnormal 12-lead ECG.
17. Current or previous malignant disease of the pelvis. Subjects with a history of (non-pelvic) cancer are considered eligible if the subje
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method