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

Primary Purpose

Overactive Bladder, Postmenopausal Disorder, Urination Disorders

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Solifenacin Succinate Tablets
Estrogen
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Solifenacin Succinate Tablets, Estrogen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Solifenacin Succinate Tablets and Estrogen capsules

Solifenacin Succinate Tablets

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference between the mean urgent micturition times (24h) and the baseline value

Full Information

First Posted
April 10, 2013
Last Updated
March 19, 2014
Sponsor
Peking Union Medical College Hospital
Collaborators
Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01833663
Brief Title
Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
Acronym
OAB
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Postmenopausal Disorder, Urination Disorders
Keywords
Overactive Bladder, Solifenacin Succinate Tablets, Estrogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin Succinate Tablets and Estrogen capsules
Arm Type
Experimental
Arm Description
Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
Arm Title
Solifenacin Succinate Tablets
Arm Type
Active Comparator
Arm Description
Solifenacin Succinate Tablets (5mg/d) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate Tablets
Intervention Type
Drug
Intervention Name(s)
Estrogen
Primary Outcome Measure Information:
Title
Difference between the mean urination times (24h) at the end of treatment and the baseline value
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difference between the mean urgent micturition times (24h) and the baseline value
Time Frame
on week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Zhu, doctor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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