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Completed

NCT Number: NCT01833663

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Solifenacin Succinate Tablets

Drug

Estrogen

Drug

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: on week 12

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Astellas Pharma China, Inc.
  • Beijing CAT Science Co., Ltd.

Registry information

Official study title

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

Acronym: OAB

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2013
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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