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Overactive BladderPhase 2OVADERNCT04545580

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

A Phase 2 study testing BAY1817080 in people with Overactive Bladder, run by Bayer at 28 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
BAY1817080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
28 sitesin 9 countries
Study dates
16 Sep 2020to 21 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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 locations and contacts

28 sites in 9 countries.

28 sites in 9 countries

Czechia7 sites

  • Afimed s.r.o

    Benešov, 256 01

  • Gynekologie Cheb s.r.o.

    Cheb, 350 02

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

    Olomouc, 772 00

  • GynCare MUDr. Michael Svec s.r.o.

    Pilsen, 326 00

  • Urocentrum Praha, s.r.o.

    Prague, 120 00

  • Androgeos - private center of urology and andrology

    Prague, 160 00

  • Fakultní nemocnice Bulovka

    Prague, 180 00

Other trials in Czechia

Poland5 sites

  • Medico Praktyka Lekarska

    Krakow, 31-315

  • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

    Lublin, 20-632

  • Centrum Urologiczne Sp. z o.o.

    Mysłowice, 41-400

  • NZOZ Heureka

    Piaseczno, 05-500

  • Przychodnia Lekarska Eskulap

    Skierniewice, 96-100

Other trials in Poland

Germany4 sites

  • Urologicum Duisburg - Praxis Walsum

    Duisburg, North Rhine-Westphalia, 47169

  • Urologicum

    Eisleben Lutherstadt, Saxony-Anhalt, 06295

  • Praxis Hr. Dr. M. Markov

    Halle, Saxony-Anhalt, 06132

  • Überörtliche Gemeinschaftspraxis "Urologie Neandertal"

    Mettmann, North Rhine-Westphalia, 40822

Other trials in Germany

Portugal3 sites

  • CHULN - Hospital Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar Universitario do Porto

    Porto, 4050

  • CHUSJ - Hospital Sao Joao

    Porto, 4200-319

Other trials in Portugal

Australia2 sites

  • Emeritus Research

    Botany, New South Wales, 2019

  • Emeritus Research

    Camberwell, Victoria, 3124

Other trials in Australia

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

New Zealand2 sites

  • Canterbury Urology Research Trust

    Christchurch, 8013

  • Tauranga Urology Research Limited

    Tauranga, 3112

Other trials in New Zealand

Sweden2 sites

  • Göteborgs Urologmottagning

    Gothenburg, 411 36

  • Urogyn

    Solna, 170 73

Other trials in Sweden

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

About this study

Official title: 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

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.

Read more

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).

Being tested
Placebo, BAY1817080
Keywords
Urinary Bladder, Overactive, OAB, Urinary incontinence, Urinary urgency, Urgency, Micturition
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • BAY1817080Drug

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

Study groups in NCT04545580
Study groupRoleWhat they receive
Treatment period: PlaceboPlacebo comparatorThis 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.
Receives: Drug: Placebo
Treatment period: BAY1817080ExperimentalThis 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.
Receives: Drug: BAY1817080

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline up to 12 weeks

Secondary outcomes (7)

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

    Measured: From baseline up to 12 weeks

  2. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes/24 hours

    Measured: From baseline up to 12 weeks

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

    Measured: From baseline up to 12 weeks

  4. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours

    Measured: From baseline up to 12 weeks

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

    Measured: From baseline up to 12 weeks

  6. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition

    Measured: From baseline up to 12 weeks

  7. Incidence of adverse events

    Measured: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2020
  2. Study start16 Sep 2020
  3. Primary completion22 Dec 2021
  4. Study completion21 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545580
Sponsor's protocol ID
19733
Other IDs
2019-002575-34, 2019
Acronym
OVADER
Status last verified
Dec 2022
First submitted
4 Sep 2020
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • 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.

    PubMed 34978027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1817080 in people with Overactive Bladder, run by Bayer at 28 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Czechia, Poland, Germany, Portugal, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From baseline up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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