NIAGARA
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, Multicenter, Phase 2a, Proof-of-Concept Study of ASP8302 in Subjects with Underactive Bladder
IRAS ID
248895
Contact name
Christopher Chapple
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2017-003693-13
Duration of Study in the UK
1 years, months, days
Research summary
Underactive Bladder (UAB) is a troubling and largely underdiagnosed but significant global health issue, particularly in elderly patients.
Patients with UAB are unable to empty their bladder properly and/or completely, often leading to distressing lower urinary tract symptoms, increased postvoid residual volumes (PVRs), which is the amount of urine remaining in the bladder after emptying has occurred, and recurrent urinary tract infections (UTIs) that can significantly impact quality of life (QoL). In addition, if PVRs and UTIs are not properly treated this may result in more serious complications such as kidney failure or acute urinary retention.
Patients may have a combination of a weakened sense of when the bladder is full, increased bladder outlet obstruction, and/or reduced contraction strength of the bladder muscles sufficiently, resulting in incomplete bladder emptying. There are no effective medication treatments available for UAB.
Participants will be allocated by chance to one of two treatment groups. The treatment groups are:
-ASP8302 100 mg once daily
-Placebo once daily (A placebo is a substance with no effects that a doctor gives to a patient instead of a drug)Half of participants will receive placebo for the whole study. Regular treatment will be provided regardless of the group to which the participant is allocated. Because we do not know yet if ASP8302 is efficacious to treat UAB, we need to compare the two treatment groups. The results of the different groups will then be analysed and compared.
Participation in the entire study will last for 8 weeks (at maximum 9 weeks). During this period 5 visits to the hospital will take place.
Approximately 125 participants will be enrolled in the screening period to randomise 100 participants; 100 participants from approximately 7 countries within East and West Europe and Japan. The number of randomised participants may be increased from 100 up to a maximum of 130.
This study is being sponsored by Astellas Pharma Europe B.V.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0346
Date of REC Opinion
12 Feb 2019
REC opinion
Further Information Favourable Opinion