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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2013

Interventions

  • Drug: Solifenacin Succinate Tablets
  • Drug: Estrogen

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Collaborator
    • Astellas Pharma China, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lan Zhu, doctor, Principal Investigator, Peking Union Medical College Hospital

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