Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women

Peking Union Medical College Hospital1 site in 1 country200 target enrollmentOctober 2011

ConditionsOveractive Bladder Postmenopausal Disorder Urination Disorders

InterventionsSolifenacin Succinate Tablets Estrogen

DrugsSolifenacin Succinate Tablets Estrogen

Overview

Phase: Phase 4
Intervention: Solifenacin Succinate Tablets
Conditions: Overactive Bladder
Sponsor: Peking Union Medical College Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: Difference between the mean urination times (24h) at the end of treatment and the baseline value
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multi-site, randomized, opened and parallel-controlled clinical study.

The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

October 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Post-menopausal women aged ≤
•Signing of ICF.
•Willing to and able to correctly complete the urination diary.
•Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
•No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.

Exclusion Criteria

•Clinically-significant dysuria(at the investigators' viewpoints).
•Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
•At the ongoing intubatton or the intermittent self-intubatton.
•Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
•Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
•Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study).
•Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions
•Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose.
•Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints.
•Participation in other clinical studies within 30d before the random grouping.