Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)

NCT04545580 | Completed Phase 2

• 2 other identifiers: 197332019-002575-34
• Study Type: interventional
• Target: 99
• Locations: 8 countries
• Sites: 26

Brief Summary

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).

Conditions

Overactive Bladder

Keywords

Urinary Bladder, Overactive; OAB; Urinary incontinence; Urinary urgency; Urgency; Micturition

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline up to 12 weeks

Secondary Outcomes (7)

• Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes/24 hours

  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

  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

  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

  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

  From baseline up to 12 weeks

Study Arms (2)

Treatment period: Placebo

PLACEBO COMPARATOR

This arm consists of participants who complete the run-in period, and are still eligible, according to all in- and exclusion criteria for diagnosis of OAB with UUI based on bladder diary baseline data. Participants will be randomized to 12 weeks of double-blind treatment with matching placebo.

Drug: Placebo

Treatment period: BAY1817080

EXPERIMENTAL

This arm consists of participants who complete the run-in period, and are still eligible, according to all in- and exclusion criteria for diagnosis of OAB with UUI based on bladder diary baseline data. Participants will be randomized to 12 weeks of double-blind treatment with BAY1817080.

Drug: BAY1817080

Interventions

Placebo DRUG

Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)

Treatment period: Placebo

BAY1817080 DRUG

BAY1817080 will be taken twice daily orally as tablet(s)

Treatment period: BAY1817080

Eligibility Criteria

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

You may qualify if:

• at screening：
• Adults ≥ 18 years of age at the time of signing the informed consent
• Have "wet" OAB symptoms (urgency, frequency and urinary incontinence) for ≥ 3 months prior to screening visit
• Women of childbearing potential (WOCBP) must agree to use acceptable effective or highly effective contraceptive methods
• Capable of giving signed informed consent
• Willing and able to complete the electronic bladder diary and questionnaires
• at baseline (to be checked at V3, prior to randomization):
• Completion of all 3 days of 3-day electronic bladder diary during run-in phase
• Compliance of ≥80% with intake of study intervention during run-in
• Frequency of micturition on average ≥ 8 episodes/24 hours during the run-in phase according to 3-day electronic bladder diary
• Frequency of urgency urinary incontinence on average ≥ 1 episode/24 hours during the run-in phase according to 3-day electronic bladder diary

You may not qualify if:

• Polyuria known or based on the clinical evidence during the run-in phase recorded in the 3-day electronic bladder diary and the investigator´s clinical judgement
• Significant stress incontinence or mixed stress/urgency incontinence
• Post-void residual volume (PVR) \> 150 mL at Visit 1 or at Visit 3
• In need of catheterization (indwelling or intermittent)
• Clinically significant urinary outflow obstruction
• Previous pelvic radiation, or previous or current malignant disease of pelvic organs
• Neurogenic bladder
• Bladder pain syndrome/interstitial cystitis
• Recurrent and/or symptomatic bladder stones
• Current symptomatic or recent (within 30 days prior to Visit 1), or recurrent (2 or more infections within 6 months, or \> 3 infections within 12 months) urinary tract infection
• Unexplained macro- or micro-hematuria
• Diabetes insipidus
• Diabetes mellitus with inadequate glycemic control as indicated by HbA1C result of \> 8% at screening
• Clinically significant cardiovascular or cerebrovascular disease
• Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg

Sponsors & Collaborators

• Bayer: lead

Study Sites (28)

Emeritus Research

Botany, New South Wales, 2019, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Afimed s.r.o

Benešov, 256 01, Czechia

Location

Gynekologie Cheb s.r.o.

Cheb, 350 02, Czechia

Location

G-Centrum Olomouc s.r.o. Dr. Skrivanek

Olomouc, 772 00, Czechia

Location

GynCare MUDr. Michael Svec s.r.o.

Pilsen, 326 00, Czechia

Location

Urocentrum Praha, s.r.o.

Prague, 120 00, Czechia

Location

Androgeos - private center of urology and andrology

Prague, 160 00, Czechia

Location

Fakultní nemocnice Bulovka

Prague, 180 00, Czechia

Location

Urologicum Duisburg - Praxis Walsum

Duisburg, North Rhine-Westphalia, 47169, Germany

Location

Überörtliche Gemeinschaftspraxis "Urologie Neandertal"

Mettmann, North Rhine-Westphalia, 40822, Germany

Location

Urologicum

Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany

Location

Praxis Hr. Dr. M. Markov

Halle, Saxony-Anhalt, 06132, Germany

Location

Canterbury Urology Research Trust

Christchurch, 8013, New Zealand

Location

Tauranga Urology Research Limited

Tauranga, 3112, New Zealand

Location

Medico Praktyka Lekarska

Krakow, 31-315, Poland

Location

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, 20-632, Poland

Location

Centrum Urologiczne Sp. z o.o.

Mysłowice, 41-400, Poland

Location

NZOZ Heureka

Piaseczno, 05-500, Poland

Location

Przychodnia Lekarska Eskulap

Skierniewice, 96-100, Poland

Location

CHULN - Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Universitario do Porto

Porto, 4050, Portugal

Location

CHUSJ - Hospital Sao Joao

Porto, 4200-319, Portugal

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Göteborgs Urologmottagning

Gothenburg, 411 36, Sweden

Location

Urogyn

Solna, 170 73, Sweden

Location

Related Publications (1)

• Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.

  PMID: 34978027 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

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; Urination Disorders

Study Design

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

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: September 16, 2020
• Primary Completion: December 22, 2021
• Study Completion: January 21, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3); SE (2); AU (2); CZ (7); DE (4); NZ (2); PL (5); SG (1)