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

NCT ID: NCT00979472

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-06-30

Brief Summary

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

Conditions

Urinary Bladder, Overactive; Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

with urgency

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

oral

without urgency

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

oral

Interventions

Solifenacin

oral

Intervention Type: DRUG

Other Intervention Names

YM905; Vesicare

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myung-Soo Choo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myung-Soo Choo, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Daegu, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Inchon, , South Korea

Jeonnam, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Countries

South Korea

References

Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.

Reference Type: DERIVED

PMID: 25401784 (View on PubMed)

Other Identifiers

VC-2009-0014

Identifier Type: -

Identifier Source: org_study_id