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

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma China, Inc.
Beijing CAT Science Co., Ltd.
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01833663
First received: April 10, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Postmenopausal Disorder
Urination Disorders
Drug: Solifenacin Succinate Tablets
Drug: Estrogen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Difference between the mean urination times (24h) at the end of treatment and the baseline value [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between the mean urgent micturition times (24h) and the baseline value [ Time Frame: on week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solifenacin Succinate Tablets and Estrogen capsules
Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
Drug: Solifenacin Succinate Tablets Drug: Estrogen
Active Comparator: Solifenacin Succinate Tablets
Solifenacin Succinate Tablets (5mg/d) for 12 weeks
Drug: Solifenacin Succinate Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833663

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Astellas Pharma China, Inc.
Beijing CAT Science Co., Ltd.
Investigators
Principal Investigator: Lan Zhu, doctor Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01833663     History of Changes
Other Study ID Numbers: XH-WXK-001
Study First Received: April 10, 2013
Last Updated: March 19, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
Overactive Bladder
Solifenacin Succinate Tablets
Estrogen

Additional relevant MeSH terms:
Urination Disorders
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Estrogens
Solifenacin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014