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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00979472
First received: September 17, 2009
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
Overactive Bladder
Drug: Solifenacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • change of micturition frequency on a 3-day voiding diary [ Time Frame: after 12-week treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in patient's perception of bladder condition [ Time Frame: after 12-week treatment ] [ Designated as safety issue: No ]
  • change in OAB symptom scores [ Time Frame: after 12-week treatment ] [ Designated as safety issue: No ]
  • patient's satisfaction with the treatment [ Time Frame: after 12-week treatment ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: with urgency Drug: Solifenacin
oral
Other Names:
  • YM905
  • Vesicare
Experimental: without urgency Drug: Solifenacin
oral
Other Names:
  • YM905
  • Vesicare

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00979472

Locations
Korea, Republic of
Daegu, Korea, Republic of, 700-712
Daegu, Korea, Republic of, 705-718
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, 135-705
Seoul, Korea, Republic of, 135-170
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00979472     History of Changes
Other Study ID Numbers: VC-2009-0014
Study First Received: September 17, 2009
Last Updated: August 16, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Solifenacin
Overactive bladder
Micturition
Urinary urgency
Vesicare

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

ClinicalTrials.gov processed this record on September 18, 2014