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

Overactive Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833663
• Other study ID #: XH-WXK-001
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2013
• Last updated: March 19, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Overactive Bladder
• Postmenopausal Disorder
• Urinary Bladder, Overactive
• Urination Disorders

Intervention

Drug:
• Solifenacin Succinate Tablets

• Estrogen

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the mean urination times (24h) at the end of treatment and the baseline value		12 weeks	No
Secondary	Difference between the mean urgent micturition times (24h) and the baseline value		on week 12	No