A Study of ASP8302 in Participants With Underactive Bladder (NCT03702777) | Clinical Trial Compass
CompletedPhase 2
A Study of ASP8302 in Participants With Underactive Bladder
Germany, Japan135 participantsStarted 2018-11-20
Plain-language summary
The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
At visit 1:
* Subject is diagnosed with UAB, defined as a bothersome chronic incomplete bladder emptying:
* clinical condition is present for ā„ 6 months before screening, and
* subject has a PVR ā„ 75 mL (measured by ultrasound after uroflowmetry; V1-PVRUS1).
* Subject on clean intermittent catheterization (CIC) should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC.
* Female subject must either:
* Be of non-childbearing potential; post-menopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
* Or, if of childbearing potential; agrees not to try to become pregnant during the study and for 28 days after the final study drug administration, agrees to have a serum pregnancy test on all visits, have a negative serum pregnancy test at the screening visit, and agrees to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
* Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, andā¦
What they're measuring
1
Change From Baseline in PVR After Standardized Bladder Filling Measured by Catheterization (PVRc2) at Week 4