Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

February 1, 2016 updated by: Myung-Soo Choo, Asan Medical Center

Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency

The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 4

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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
      • Daegu, Korea, Republic of, 700-712
      • Daejon, Korea, Republic of, 301-721
      • Inchon, Korea, Republic of, 400-711
      • Jeonnam, Korea, Republic of, 519-809
      • Pusan, Korea, Republic of, 602-739
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 135-170
      • Seoul, Korea, Republic of, 135-705

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For the without-urgency group:

    • urinary frequency ≥ 8 micturitions per 24 hours no urgency on voiding diary (1 or 2 on a 5 urgency scale)

  • For the with-urgency group:

    • urinary frequency ≥ 8 micturitions per 24 hours symptoms of urinary urgency≥ 2/day on the voiding diary (3 to 5 on a 5 urgency scale)
  • Symptoms lasting for more than 3 months

Exclusion Criteria:

  • Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
  • Total daily urine volume of > 3000 mL as verified on the micturition diary before randomization
  • Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
  • Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  • Symptomatic acute urinary tract infection (UTI) during the run-in period
  • Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
  • Diagnosed or suspected of interstitial cystitis
  • Uninvestigated hematuria or hematuria secondary to a malignant disease
  • Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine> 100mL of functional bladder capacity)
  • Patients with marked cystocele or other clinically significant pelvic prolapse

  • Treatment within 14 days preceding randomization, or expected to initiate treatment during the study with:

    • Any anticholinergic drugs other than a randomized trial drug
    • Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
  • On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  • Receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study
  • An indwelling catheter or practicing intermittent self-catheterization
  • Use of any investigational drug within 1 month prior to the start of the study
  • Patients with chronic constipation or history of severe constipation
  • Pregnant or nursing women
  • Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to the start of the study and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy)
  • Patients who have bladder cancer or prostate cancer
  • Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
  • Patients who have neurological disease
  • Patients who have psychological disease
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with urgency
Drug: Solifenacin
oral
Other Names:
  • Vesicare
  • YM905
Experimental: without urgency
Drug: Solifenacin
oral
Other Names:
  • Vesicare
  • YM905

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of micturition frequency on a 3-day voiding diary
Time Frame: after 12-week treatment
after 12-week treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
change in patient's perception of bladder condition
Time Frame: after 12-week treatment
after 12-week treatment
change in OAB symptom scores
Time Frame: after 12-week treatment
after 12-week treatment
patient's satisfaction with the treatment
Time Frame: after 12-week treatment
after 12-week treatment

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Astellas Pharma Korea, Inc.

Investigators

  • Principal Investigator: Myung-Soo Choo, Professor, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC-2009-0014

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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