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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Astellas Pharma China, Inc.; Beijing CAT Science Co., Ltd.
• Treatments: Estrogens; Solifenacin Succinate

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.