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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urination Disorders; Postmenopausal Disorder
• Intervention / Treatment: Drug: Estrogen; Drug: Solifenacin Succinate Tablets

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between the mean urination times (24h) at the end of treatment and the baseline value	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference between the mean urgent micturition times (24h) and the baseline value	on week 12

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Astellas Pharma China, Inc.; Beijing CAT Science Co., Ltd.
• Investigators: Principal Investigator: Lan Zhu, Doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 14, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Overactive Bladder; Estrogen; Solifenacin Succinate Tablets
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Disease; Urination Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Solifenacin Succinate
• Other Study ID Numbers: XH-WXK-001