NL-OMON48804已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2a, Proof-of-Concept Study of ASP8302 in Subjects with Underactive Bladder - Astellas ASP8302 / NIAGARA study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 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.
- •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 or breastfeeding partner(s) must agree to
- •remain abstinent or use a condom for the duration of the pregnancy or time
- •partner is breastfeeding 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
- 另有 5 项未显示
排除标准
- •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.
- •9. Prohibited medications or subject is using restricted medications under
- •conditions different to those specified in the concomitant medication section.
- •10. Known or suspected hypersensitivity to ASP8302 or any of the inactive
- •ingredients.
- •11. Inflammatory bowel disease or clinically significant diarrhea.
- 另有 7 项未显示
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