Status:
COMPLETED
Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Astellas Pharma China, Inc.
Beijing CAT Science Co., Ltd.
Conditions:
Overactive Bladder
Postmenopausal Disorder
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
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 Sol...
Eligibility Criteria
Inclusion
- Post-menopausal women aged ≤75.
- 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
- 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.
- No completion of urination diary according to relevant instructions.
- Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01833663
Start Date
October 1 2011
End Date
October 1 2013
Last Update
March 20 2014
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730