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

NCT01833663 | Completed Phase 4 DMC

• 1 other identifier: XH-WXK-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Postmenopausal Disorder; Urination Disorders

Keywords

Overactive Bladder; Solifenacin Succinate Tablets; Estrogen

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  on week 12

Study Arms (2)

Solifenacin Succinate Tablets and Estrogen capsules

EXPERIMENTAL

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

Drug: Solifenacin Succinate Tablets; Drug: Estrogen

Solifenacin Succinate Tablets

ACTIVE COMPARATOR

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

Drug: Solifenacin Succinate Tablets

Interventions

Solifenacin Succinate Tablets DRUG

Solifenacin Succinate Tablets; Solifenacin Succinate Tablets and Estrogen capsules

Estrogen DRUG

Solifenacin Succinate Tablets and Estrogen capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Astellas Pharma China, Inc.: collaborator
• Beijing CAT Science Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urination Disorders

Interventions

Solifenacin Succinate; Estrogens

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lan Zhu, doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 17, 2013
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

CN (1)