Trial Condition(s):

Overactive Bladder

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

Bayer Identifier:

19733

ClinicalTrials.gov Identifier:

NCT04545580

EudraCT Number:

2019-002575-34

Study Completed

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).

Inclusion Criteria
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
Exclusion Criteria
- 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
- 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)

Trial Summary

Enrollment Goal
99
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Urogyn

Solna, Sweden, 170 73

Status
Completed
 
Locations

Göteborgs Urologmottagning

Göteborg, Sweden, 411 36

Status
Completed
 
Locations

Urocentrum Praha, s.r.o.

Praha 2, Czech Republic, 120 00

Status
Completed
 
Locations

Androgeos - private center of urology and andrology

Praha 6, Czech Republic, 160 00

Status
Completed
 
Locations

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

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, Poland, 20-632

Status
Completed
 
Locations

NZOZ Heureka

Piaseczno, Poland, 05-500

Status
Completed
 
Locations

Centrum Urologiczne Sp. z o.o.

Myslowice, Poland, 41-400

Status
Completed
 
Locations

CHUSJ - Hospital Sao Joao

Porto, Portugal, 4200-319

Status
Completed
 
Locations

Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050

Status
Completed
 
Locations

Praxis Hr. Dr. M. Markov

Halle, Germany, 06132

Status
Completed
 
Locations

Medico Praktyka Lekarska

Krakow, Poland, 31-315

Status
Completed
 
Locations

GynCare MUDr. Michael Svec s.r.o.

Plzen, Czech Republic, 326 00

Status
Completed
 
Locations

Fakultní nemocnice Bulovka

Praha 8, Czech Republic, 180 00

Status
Completed
 
Locations

CHULN - Hospital Santa Maria

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Urologicum

Lutherstadt Eisleben, Germany, 06295

Status
Completed
 
Locations

Emeritus Research

Botany, Australia, 2019

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Emeritus Research

Camberwell, Australia, 3124

Status
Completed
 
Locations

Tauranga Urology Research Limited

Tauranga, New Zealand, 3112

Status
Completed
 
Locations

Canterbury Urology Research Trust

Christchurch, New Zealand, 8013

Status
Completed
 
Locations

Urologicum Duisburg - Praxis Walsum

Duisburg, Germany, 47169

Status
Completed
 
Locations

Überörtliche Gemeinschaftspraxis "Urologie Neandertal"

Mettmann, Germany, 40822

Status
Completed
 
Locations

Afimed s.r.o

Benesov, Czech Republic, 256 01

Status
Completed
 
Locations

Gynekologie Cheb s.r.o.

Cheb, Czech Republic, 350 02

Status
Completed
 
Locations

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Status
Completed
 
Locations

Przychodnia Lekarska Eskulap

Skierniewice, Poland, 96-100

Status
Completed
 

Trial Design