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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04545580




Registration number
NCT04545580
Ethics application status
Date submitted
4/09/2020
Date registered
11/09/2020

Titles & IDs
Public title
Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)
Scientific 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
Secondary ID [1] 0 0
2019-002575-34
Secondary ID [2] 0 0
19733
Universal Trial Number (UTN)
Trial acronym
OVADER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - BAY1817080

Placebo comparator: 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.

Experimental: 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.


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

Treatment: Drugs: BAY1817080
BAY1817080 will be taken twice daily orally as tablet(s)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline up to 12 weeks
Secondary outcome [1] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes/24 hours
Timepoint [1] 0 0
From baseline up to 12 weeks
Secondary outcome [2] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes/24 hours
Timepoint [2] 0 0
From baseline up to 12 weeks
Secondary outcome [3] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours
Timepoint [3] 0 0
From baseline up to 12 weeks
Secondary outcome [4] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours
Timepoint [4] 0 0
From baseline up to 12 weeks
Secondary outcome [5] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours
Timepoint [5] 0 0
From baseline up to 12 weeks
Secondary outcome [6] 0 0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
Timepoint [6] 0 0
From baseline up to 12 weeks
Secondary outcome [7] 0 0
Incidence of adverse events
Timepoint [7] 0 0
From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/01/2022
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Emeritus Research - Botany
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Czechia
State/province [3] 0 0
Benesov
Country [4] 0 0
Czechia
State/province [4] 0 0
Cheb
Country [5] 0 0
Czechia
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czechia
State/province [6] 0 0
Plzen
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 2
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 6
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 8
Country [10] 0 0
Germany
State/province [10] 0 0
Nordrhein-Westfalen
Country [11] 0 0
Germany
State/province [11] 0 0
Sachsen-Anhalt
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Tauranga
Country [14] 0 0
Poland
State/province [14] 0 0
Krakow
Country [15] 0 0
Poland
State/province [15] 0 0
Lublin
Country [16] 0 0
Poland
State/province [16] 0 0
Myslowice
Country [17] 0 0
Poland
State/province [17] 0 0
Piaseczno
Country [18] 0 0
Poland
State/province [18] 0 0
Skierniewice
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Portugal
State/province [20] 0 0
Porto
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Sweden
State/province [22] 0 0
Göteborg
Country [23] 0 0
Sweden
State/province [23] 0 0
Solna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04545580