A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

April 9, 2008 updated by: Astellas Pharma Inc

A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100000
      • Chong Qing, China, 404000
      • Hang Zhou, China, 310000
      • Shanghai, China, 200000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients willing and able to complete the micturition diary correctly
  • Patients experiencing frequency of micturition as verified in the diary
  • Patients experiencing significant post void residual volume
  • OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria:

  • Significant post void residual volume
  • Patients with indwelling catheters or practicing intermittent self- catheterization
  • Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: solifenacin succinate
Oral
Other Names:
  • Vesicare
  • YM905
Active Comparator: 2
Drug: tolterodine
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean number of micturitions per 24 hours
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean volume voided per micturition
Time Frame: 8 Weeks
8 Weeks
Change from baseline in mean number of incontinence episodes per 24 hours
Time Frame: 8 Weeks
8 Weeks
Change from baseline in mean urgency frequency per 24 hours
Time Frame: 8 Weeks
8 Weeks
Change from baseline in mean nocturia episodes per 24 hours
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Principal Investigator: Use Central Contact, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (Estimate)

August 25, 2006

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 9, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90506/CHoTD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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