Clinical trial NCT01833663: Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Postmenopausal Disorder
Urination Disorders
Keywords: Overactive Bladder
Solifenacin Succinate Tablets
Estrogen
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma China, Inc.
name: Beijing CAT Science Co., Ltd.
First posted: 2013-04-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 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.
* No completion of urination diary according to relevant instructions.
* Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.

Primary outcomes:
measure: Difference between the mean urination times (24h) at the end of treatment and the baseline value
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference between the mean urgent micturition times (24h) and the baseline value
timeFrame: on week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu, doctor
role: PRINCIPAL_INVESTIGATOR
References: