19733 OVADER BAY1817080
Research type
Research Study
Full title
A randomised, placebo-controlled, double-blind, parallel-group, multi-centre, 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.
IRAS ID
277781
Contact name
Christopher Chapple
Contact email
Sponsor organisation
Bayer AG
Eudract number
2019-002575-34
Duration of Study in the UK
0 years, 11 months, 18 days
Research summary
Research Summary
A Clinical study to evaluate the treatment effect and safety of BAY 1817080 in patients with overactive bladder
Overactive bladder (OAB) is a common disorder that affects men and women with a similar prevalence overall. OAB is a characterised by symptoms of urgency, urinary frequency and nocturia, with or without urgency incontinence in the absence of any other underlying pathology.
The main treatment measures include lifestyle guidance, pelvic floor muscle training, bladder training, and eventually evolves to drug treatment. The drugs available for OAB offer some symptom relief but might cause side effects and many patients still complain of lack of efficacy.
BAY 1817080 has a different mechanism of action from the currently approved drugs for OAB and might be an effective new treatment option for OAB.
The purpose of this study is to determine, for the first time, whether the P2X3 receptor antagonist BAY 1817080 has therapeutic benefit in OAB patients with urgency urinary incontinence (UUI), as well as determination of safety and tolerability in this patient population.
Potential eligible participants to join the study are at least 18 years of age and have symptoms of overactive bladder (OAB) with urinary incontinence for at least three months. Participants need to be able and willing to complete an electronic bladder diary and should not have any severe or unstable medical diseases.
About 100 participants will take part in the study, which is planned to be conducted in 6 European countries (UK, Czech Republic, Germany, Poland, Portugal and Sweden). There are about 15 study sites across participating countries, both hospital and private clinics mainly specialized in urology or gynaecology.
For those who join the study, it is expected that study takes about 5 months (around 20-22 weeks). During the study, participants are expected to visit the clinic 9 times overall.
Summary of Results
The lay summary of the study results can be downloaded in the local language from the following address: https://clinicaltrials.bayer.com/study/19733/REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0109
Date of REC Opinion
31 Mar 2020
REC opinion
Further Information Favourable Opinion