Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04545580
Registration number
NCT04545580
Ethics application status
Date submitted
4/09/2020
Date registered
11/09/2020
Date last updated
22/12/2022
Titles & IDs
Public title
Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)
Query!
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
Query!
Secondary ID [1]
0
0
2019-002575-34
Query!
Secondary ID [2]
0
0
19733
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
OVADER
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From baseline up to 12 weeks
Query!
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
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From baseline up to 12 weeks
Query!
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
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
From baseline up to 12 weeks
Query!
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
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From baseline up to 12 weeks
Query!
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
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
From baseline up to 12 weeks
Query!
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
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
From baseline up to 12 weeks
Query!
Secondary outcome [6]
0
0
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From baseline up to 12 weeks
Query!
Secondary outcome [7]
0
0
Incidence of adverse events
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/09/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/01/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
99
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Emeritus Research - Botany
Query!
Recruitment hospital [2]
0
0
Emeritus Research - Camberwell
Query!
Recruitment postcode(s) [1]
0
0
2019 - Botany
Query!
Recruitment postcode(s) [2]
0
0
3124 - Camberwell
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Steiermark
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Innsbruck
Query!
Country [3]
0
0
Czechia
Query!
State/province [3]
0
0
Benesov
Query!
Country [4]
0
0
Czechia
Query!
State/province [4]
0
0
Cheb
Query!
Country [5]
0
0
Czechia
Query!
State/province [5]
0
0
Olomouc
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Plzen
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Praha 2
Query!
Country [8]
0
0
Czechia
Query!
State/province [8]
0
0
Praha 6
Query!
Country [9]
0
0
Czechia
Query!
State/province [9]
0
0
Praha 8
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Nordrhein-Westfalen
Query!
Country [11]
0
0
Germany
Query!
State/province [11]
0
0
Sachsen-Anhalt
Query!
Country [12]
0
0
New Zealand
Query!
State/province [12]
0
0
Christchurch
Query!
Country [13]
0
0
New Zealand
Query!
State/province [13]
0
0
Tauranga
Query!
Country [14]
0
0
Poland
Query!
State/province [14]
0
0
Krakow
Query!
Country [15]
0
0
Poland
Query!
State/province [15]
0
0
Lublin
Query!
Country [16]
0
0
Poland
Query!
State/province [16]
0
0
Myslowice
Query!
Country [17]
0
0
Poland
Query!
State/province [17]
0
0
Piaseczno
Query!
Country [18]
0
0
Poland
Query!
State/province [18]
0
0
Skierniewice
Query!
Country [19]
0
0
Portugal
Query!
State/province [19]
0
0
Lisboa
Query!
Country [20]
0
0
Portugal
Query!
State/province [20]
0
0
Porto
Query!
Country [21]
0
0
Singapore
Query!
State/province [21]
0
0
Singapore
Query!
Country [22]
0
0
Sweden
Query!
State/province [22]
0
0
Göteborg
Query!
Country [23]
0
0
Sweden
Query!
State/province [23]
0
0
Solna
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04545580
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04545580
Download to PDF