check_circleStudy Completed

Overactive bladder

Clinical study to evaluate the treatment effect and safety of BAY1817080 in patients with overactive bladder (OAB)

Trial purpose

The aim of the study is to determine how well the drug BAY1817080 works in OAB patients with urgency urinary incontinence (UUI), defined as involuntary leakage of urine, accompanied or immediately preceded by a sudden compelling desire to void.
BAY1817080 is a new drug under development which blocks proteins expressed on the sensory nerves in the bladder. These nerves seem to overreact in OAB patients.
This study will test if the treatment with BAY1817080 will reduce the frequency of OAB symptoms. The frequency of OAB symptoms before the treatment and the frequency after 4, 8 and 12 weeks of treatment will be compared.
Another important objective of this study will be the assessment of BAY1817080 safety and tolerability in this patient population.
BAY1817080 will be compared to a "placebo". A placebo tablet looks like the study drug but does not have any medicine in it. Using a placebo helps to learn if the study drug works. Each participant is expected to take part in the study for about 5 months (around 20-22 weeks).

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
99
Trial Dates
September 2020 - January 2022
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
UrogynSolna, 170 73, Sweden
Completed
Göteborgs UrologmottagningGöteborg, 411 36, Sweden
Completed
Urocentrum Praha, s.r.o.Praha 2, 120 00, Czechia
Completed
Androgeos - private center of urology and andrologyPraha 6, 160 00, Czechia
Completed
G-Centrum Olomouc s.r.o. Dr. SkrivanekOlomouc, 772 00, Czechia
Completed
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.CLublin, 20-632, Poland
Completed
NZOZ HeurekaPiaseczno, 05-500, Poland
Completed
Centrum Urologiczne Sp. z o.o.Myslowice, 41-400, Poland
Completed
CHUSJ - Hospital Sao JoaoPorto, 4200-319, Portugal
Completed
Centro Hospitalar Universitario do PortoPorto, 4050, Portugal
Withdrawn
Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Withdrawn
Praxis Hr. Dr. W. WarnackHagenow, 19230, Germany
Completed
Praxis Hr. Dr. M. MarkovHalle, 06132, Germany
Withdrawn
Praxis für Urologie Dr. Ewgeni RosengrünSchwerin, 19057, Germany
Withdrawn
Derriford HospitalPlymouth, PL6 8DH, United Kingdom
Completed
Medico Praktyka LekarskaKrakow, 31-315, Poland
Completed
GynCare MUDr. Michael Svec s.r.o.Plzen, 326 00, Czechia
Completed
Fakultní nemocnice BulovkaPraha 8, 180 00, Czechia
Completed
CHULN - Hospital Santa MariaLisboa, 1649-035, Portugal
Withdrawn
Urologische Gemeinschaftspraxis Carl-Andreas-MeilingerEmmendingen, 79312, Germany
Completed
UrologicumLutherstadt Eisleben, 06295, Germany
Completed
Emeritus ResearchBotany, 2019, Australia
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Completed
Emeritus ResearchCamberwell, 3124, Australia
Withdrawn
Keogh Institute for Medical ResearchNedlands, 6009, Australia
Completed
Tauranga Urology Research LimitedTauranga, 3112, New Zealand
Completed
Canterbury Urology Research TrustChristchurch, 8013, New Zealand
Completed
Urologicum Duisburg - Praxis WalsumDuisburg, 47169, Germany
Withdrawn
Urologie Bayenthal - Urologische Partnerschaft KölnKöln, 50968, Germany
Completed
Überörtliche Gemeinschaftspraxis "Urologie Neandertal"Mettmann, 40822, Germany
Withdrawn
Provita Centrum Medyczne sp. z o.o.Warszawa, 02-647, Poland
Completed
Afimed s.r.oBenesov, 256 01, Czechia
Completed
Gynekologie Cheb s.r.o.Cheb, 350 02, Czechia
Withdrawn
Singapore General HospitalSingapore, 169608, Singapore
Completed
KK Women's and Children's HospitalSingapore, 229899, Singapore
Withdrawn
Uromeda – urologicka ambulanceBrno Zidenice, 615 00, Czechia
Completed
Przychodnia Lekarska EskulapSkierniewice, 96-100, Poland

Primary Outcome

  • Average change from baseline over Week 4, 8 and 12 (end of treatment [EoT]) in mean number of urgency urinary incontinence (UUI) episodes/24 hours based on electronic bladder diary
    date_rangeTime Frame:
    From baseline up to 12 weeks

Secondary Outcome

  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes/24 hours
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes/24 hours
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
    date_rangeTime Frame:
    From baseline up to 12 weeks
  • Incidence of adverse events
    date_rangeTime Frame:
    From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)

Trial design

A randomized, placebo-controlled, double-blind, parallel-group, multi-center, proof-of-concept study to assess the efficacy and safety of BAY 1817080 in patients with overactive bladder (OAB) over a 12-week treatment period
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2