Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)
NCT ID: NCT04545580
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2020-09-16
2022-01-21
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment period: Placebo
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.
Placebo
Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)
Treatment period: BAY1817080
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.
BAY1817080
BAY1817080 will be taken twice daily orally as tablet(s)
Interventions
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Placebo
Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)
BAY1817080
BAY1817080 will be taken twice daily orally as tablet(s)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Clinically significant abnormal electrocardiogram (ECG) at screening
* Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C
* Laboratory values outside the inclusion range (as specified in the laboratory manual and in the reports from the central laboratory) before start of study intervention, and considered clinically relevant
* At screening:
* ALT above 2xULN OR
* AST above 2xULN OR
* total bilirubin greater than ULN OR
* AP above 2x ULN OR
* INR greater than ULN (unless on vitamin K antagonist treatment) OR
* Positive hepatitis B virus surface antigen (HBsAg) OR
* Positive hepatitis C virus antibodies (anti-HCV) and detection of mRNA (HCV-mRNA, only tested if hepatitis C virus antibodies were detected)
* Severe renal impairment as defined by estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2 calculated by Modification of Diet in Renal Disease (MDRD) formula
* Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g., excessively low body weight, Chronic bowel disease, Crohn's disease and ulcerative colitis)
* Any severe or unstable diseases or medical conditions including psychiatric disorders that might interfere with the conduct of the study, or could jeopardize the safety of the participant, or the interpretation of the results
* History of major depression within 2 years prior to screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder)
* Concurrent malignancy or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening
* Intake of prohibited medication due to potential drug-drug interaction Use of other treatments that might interfere with the conduct of the study or the interpretation of the results e.g.
* a) use of any drug treatment after start of study intervention intended for the OAB/UI symptoms other than the study intervention
* b) neuromodulation therapy and intravesical treatment - less than 12 months prior to screening or at any time during the study
* c) use of any treatment intended for other conditions but which can affect urinary bladder function during the study
* d) Non-drug treatment (e.g. physical treatment or acupuncture): permitted only if initiated ≥4 weeks prior to Screening and planned to be continued during the study)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Emeritus Research
Botany, New South Wales, Australia
Emeritus Research
Camberwell, Victoria, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Afimed s.r.o
Benešov, , Czechia
Gynekologie Cheb s.r.o.
Cheb, , Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, , Czechia
GynCare MUDr. Michael Svec s.r.o.
Pilsen, , Czechia
Urocentrum Praha, s.r.o.
Prague, , Czechia
Androgeos - private center of urology and andrology
Prague, , Czechia
Fakultní nemocnice Bulovka
Prague, , Czechia
Urologicum Duisburg - Praxis Walsum
Duisburg, North Rhine-Westphalia, Germany
Überörtliche Gemeinschaftspraxis "Urologie Neandertal"
Mettmann, North Rhine-Westphalia, Germany
Urologicum
Eisleben Lutherstadt, Saxony-Anhalt, Germany
Praxis Hr. Dr. M. Markov
Halle, Saxony-Anhalt, Germany
Canterbury Urology Research Trust
Christchurch, , New Zealand
Tauranga Urology Research Limited
Tauranga, , New Zealand
Medico Praktyka Lekarska
Krakow, , Poland
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
Lublin, , Poland
Centrum Urologiczne Sp. z o.o.
Mysłowice, , Poland
NZOZ Heureka
Piaseczno, , Poland
Przychodnia Lekarska Eskulap
Skierniewice, , Poland
CHULN - Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar Universitario do Porto
Porto, , Portugal
CHUSJ - Hospital Sao Joao
Porto, , Portugal
KK Women's and Children's Hospital
Singapore, , Singapore
Göteborgs Urologmottagning
Gothenburg, , Sweden
Urogyn
Solna, , Sweden
Countries
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References
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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.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
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Other Identifiers
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2019-002575-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19733
Identifier Type: -
Identifier Source: org_study_id