Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01833663

Collaborator

Astellas Pharma China, Inc. (Industry), Beijing CAT Science Co., Ltd. (Other)

200

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Postmenopausal Disorder Urination Disorders	Drug: Solifenacin Succinate Tablets Drug: Estrogen	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solifenacin Succinate Tablets and Estrogen capsules Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks	Drug: Solifenacin Succinate Tablets Drug: Estrogen
Active Comparator: Solifenacin Succinate Tablets Solifenacin Succinate Tablets (5mg/d) for 12 weeks	Drug: Solifenacin Succinate Tablets

Arm

Intervention/Treatment

Experimental: Solifenacin Succinate Tablets and Estrogen capsules

Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks

Drug: Solifenacin Succinate Tablets

Drug: Estrogen

Active Comparator: Solifenacin Succinate Tablets

Solifenacin Succinate Tablets (5mg/d) for 12 weeks

Drug: Solifenacin Succinate Tablets

Outcome Measures

Primary Outcome Measures

Difference between the mean urination times (24h) at the end of treatment and the baseline value [12 weeks]

Secondary Outcome Measures

Difference between the mean urgent micturition times (24h) and the baseline value [on week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.