A Study of ASP8302 in Participants With Underactive Bladder

NCT03702777 | Completed Phase 2

• 2 other identifiers: 8302-CL-02012017-003693-13
• Study Type: interventional
• Target: 135
• Locations: 6 countries
• Sites: 29

Brief Summary

The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).

Conditions

Underactive Bladder

Keywords

Underactive Bladder; ASP8302

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PVR After Standardized Bladder Filling Measured by Catheterization (PVRc2) at Week 4

  Volume of urine in the bladder after standardized bladder filling measured by catheterization (PVRc2).

  Baseline and week 4

Secondary Outcomes (2)

• Voided Volume After Standardized Bladder Filling (VV_St) at Week 4

  Week 4

• Bladder Voiding Efficiency Calculated With PVRc2 and VV-St (BVEc2) at Week 4

  Week 4

Study Arms (2)

ASP8302 100mg

EXPERIMENTAL

Participants will receive ASP8302 100mg capsules orally once daily for up to 4 weeks.

Drug: ASP8302

Placebo

PLACEBO COMPARATOR

Participants will receive ASP8302 matching placebo orally once daily for up to 4 weeks.

Drug: Placebo

Interventions

ASP8302 DRUG

Oral Capsule

ASP8302 100mg

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At visit 1:
• 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).
• Subject on clean intermittent catheterization (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.
• 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, 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.
• 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.
• Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
• 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. If the male subject has not had a vasectomy or is not sterile, 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.
• Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
• 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.
• Subject agrees not to participate in another interventional study while participating in this study.
• At visit 2:

You may not qualify if:

• At visit 1:
• Related to lower urinary tract:
• Subject has significant BOO:
• Subject has clinically significant urethral stricture (e.g., requiring surgery).
• Female subject has uterus prolapse ≥ Grade 2 Shaw's system (up 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 cm H2O on pressure flow study (PFS) (either performed on screening or within 12 months of the screening visit), or -if PFS is not available-a prostate volume (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 bladder outlet obstruction index (BOOI) is \< 40.
• Other condition that constitutes significant BOO.
• Subject is known to have urgency urinary incontinence that is clinically significant.
• Subject is known to have 1 or more bladder diverticuli that is/are clinically significant.
• Subject is known to have vesico-ureteral/renal reflux that is clinically significant.
• Subject has a urinary catheter in situ (including suprapubic catheters).
• Subject is known to have 1 of the following conditions as a primary cause for subject's 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 (e.g., HbA1C \< 7%).
• 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 (e.g., bladder augmentation or reduction surgery, latissimus dorsi detrusor myoplasty). Prior Benign Prostatic Obstruction surgery or pelvic organ prolapse surgery is allowed if performed more than 6 months prior to screening.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (29)

Site DE49001

Duisburg, Germany

Location

Site DE49002

Duisburg, Germany

Location

Site DE49004

Gronau, Germany

Location

Site DE49003

Mönchengladbach, Germany

Location

Site JP81009

Nagoya, Aichi-ken, Japan

Location

Site JP81008

Ōbu, Aichi-ken, Japan

Location

Site JP81007

Yoshida-gun, Fukui, Japan

Location

Site JP81006

Asahikawa, Hokkaido, Japan

Location

Site JP81005

Sapporo, Hokkaido, Japan

Location

Site JP81015

Sapporo, Hokkaido, Japan

Location

Site JP81002

Kobe, Hyōgo, Japan

Location

Site JP81012

Kurashiki, Okayama-ken, Japan

Location

Site JP81011

Sayama, Osaka, Japan

Location

Site JP81001

Shimotsuga-gun, Tochigi, Japan

Location

Site JP81003

Fukuoka, Japan

Location

Site JP81004

Kumamoto, Japan

Location

Site JP81010

Saga, Japan

Location

Site JP81013

Shizuoka, Japan

Location

Site NL31003

Eindhoven, Netherlands

Location

Site NL31002

Maastricht, Netherlands

Location

Site NL31001

Rotterdam, Netherlands

Location

Site PL48004

Mysłowice, Poland

Location

Site PL48003

Piaseczno, Poland

Location

Site PL48002

Szczecin, Poland

Location

Site PL48001

Warsaw, Poland

Location

Site SK42103

Košice, Slovakia

Location

Site SK42101

Nitra, Slovakia

Location

Site SK42102

Trenčín, Slovakia

Location

Site UK44002

Bristol, United Kingdom

Location

Related Publications (1)

• van Till JWO, Arita E, Kuroishi K, Croy R, Oelke M, van Koeveringe GA, Chapple CR, Yamaguchi O, Abrams P. Muscarinic-3-receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial. Neurourol Urodyn. 2022 Jun;41(5):1139-1148. doi: 10.1002/nau.24931. Epub 2022 Apr 14.

  PMID: 35419807 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results Website.

MeSH Terms

Conditions

Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 11, 2018
• Study Start: November 20, 2018
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); NL (3); JP (14); GB (1); PL (4); SL (3)