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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545580
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

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).


Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Placebo Drug: BAY1817080 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : December 22, 2021
Actual Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)

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




Primary Outcome Measures :
  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 [ Time Frame: From baseline up to 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes/24 hours [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From baseline up to 12 weeks ]
  7. Incidence of adverse events [ Time Frame: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545580


Locations
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Sponsors and Collaborators
Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04545580    
Other Study ID Numbers: 19733
2019-002575-34 ( EudraCT Number )
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Urinary Bladder, Overactive
OAB
Urinary incontinence
Urinary urgency
Urgency
Micturition
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations