Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

Phase 4 Completed 291 enrolled Asan Medical Center Astellas Pharma Korea, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.

Timeline

Start: 2009-04
Primary completion: 2010-06
Completion: 2010-06

Outcome

Missed primary endpoint

paper The lower limit of the 95% two-sided CI of the comparison of the two group means was -1.14, which is smaller than the -0.8 margin of clinical equivalence. PMID 25401784 ↗

paper It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. PMID 25401784 ↗

Publications

Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Solifenacin	Small molecule	—	Oral