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

NCT ID: NCT01833663

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin Succinate Tablets and Estrogen capsules

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

Group Type: EXPERIMENTAL

Solifenacin Succinate Tablets

Intervention Type: DRUG

Estrogen

Intervention Type: DRUG

Solifenacin Succinate Tablets

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

Group Type: ACTIVE_COMPARATOR

Solifenacin Succinate Tablets

Intervention Type: DRUG

Interventions

Solifenacin Succinate Tablets

Intervention Type: DRUG

Estrogen

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role: collaborator

Beijing CAT Science Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lan Zhu, doctor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37160401 (View on PubMed)

Other Identifiers

XH-WXK-001

Identifier Type: -

Identifier Source: org_study_id