check_circleStudy Completed
Overactive bladder
Bayer Identifier:
19733
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
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
AllAge
18 - N/ATrial summary
Enrollment Goal
99Trial Dates
September 2020 - January 2022Phase
Phase 2Could I Receive a placebo
YesProducts
Eliapixant (BAY1817080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Urogyn | Solna, 170 73, Sweden |
Completed | Göteborgs Urologmottagning | Göteborg, 411 36, Sweden |
Completed | Urocentrum Praha, s.r.o. | Praha 2, 120 00, Czechia |
Completed | Androgeos - private center of urology and andrology | Praha 6, 160 00, Czechia |
Completed | G-Centrum Olomouc s.r.o. Dr. Skrivanek | Olomouc, 772 00, Czechia |
Completed | NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C | Lublin, 20-632, Poland |
Completed | NZOZ Heureka | Piaseczno, 05-500, Poland |
Completed | Centrum Urologiczne Sp. z o.o. | Myslowice, 41-400, Poland |
Completed | CHUSJ - Hospital Sao Joao | Porto, 4200-319, Portugal |
Completed | Centro Hospitalar Universitario do Porto | Porto, 4050, Portugal |
Withdrawn | Royal Hallamshire Hospital | Sheffield, S10 2JF, United Kingdom |
Withdrawn | Praxis Hr. Dr. W. Warnack | Hagenow, 19230, Germany |
Completed | Praxis Hr. Dr. M. Markov | Halle, 06132, Germany |
Withdrawn | Praxis für Urologie Dr. Ewgeni Rosengrün | Schwerin, 19057, Germany |
Withdrawn | Derriford Hospital | Plymouth, PL6 8DH, United Kingdom |
Completed | Medico Praktyka Lekarska | Krakow, 31-315, Poland |
Completed | GynCare MUDr. Michael Svec s.r.o. | Plzen, 326 00, Czechia |
Completed | Fakultní nemocnice Bulovka | Praha 8, 180 00, Czechia |
Completed | CHULN - Hospital Santa Maria | Lisboa, 1649-035, Portugal |
Withdrawn | Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger | Emmendingen, 79312, Germany |
Completed | Urologicum | Lutherstadt Eisleben, 06295, Germany |
Completed | Emeritus Research | Botany, 2019, Australia |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Completed | Emeritus Research | Camberwell, 3124, Australia |
Withdrawn | Keogh Institute for Medical Research | Nedlands, 6009, Australia |
Completed | Tauranga Urology Research Limited | Tauranga, 3112, New Zealand |
Completed | Canterbury Urology Research Trust | Christchurch, 8013, New Zealand |
Completed | Urologicum Duisburg - Praxis Walsum | Duisburg, 47169, Germany |
Withdrawn | Urologie Bayenthal - Urologische Partnerschaft Köln | Köln, 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.o | Benesov, 256 01, Czechia |
Completed | Gynekologie Cheb s.r.o. | Cheb, 350 02, Czechia |
Withdrawn | Singapore General Hospital | Singapore, 169608, Singapore |
Completed | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Withdrawn | Uromeda – urologicka ambulance | Brno Zidenice, 615 00, Czechia |
Completed | Przychodnia Lekarska Eskulap | Skierniewice, 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 diarydate_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 hoursdate_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 hoursdate_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 hoursdate_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 hoursdate_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 hoursdate_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 micturitiondate_rangeTime Frame:From baseline up to 12 weeks
- Incidence of adverse eventsdate_rangeTime Frame:From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2