NCT04545580

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)
DRUG	BAY1817080	BAY1817080 will be taken twice daily orally as tablet(s)

Timeline

• Start date: 2020-09-16
• Primary completion: 2021-12-22
• Completion: 2022-01-21
• First posted: 2020-09-11
• Last updated: 2022-12-22

Locations

28 sites across 9 countries: Australia, Austria, Czechia, Germany, New Zealand, Poland, Portugal, Singapore, Sweden