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

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00979472

Collaborator

Astellas Pharma Korea, Inc. (Industry)

291

Enrollment

Locations

Arms

Duration (Months)

32.3

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive Overactive Bladder	Drug: Solifenacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

291 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: with urgency

Drug: Solifenacin

oral

Other Names:

YM905

Vesicare

Experimental: without urgency

Drug: Solifenacin

oral

Other Names:

YM905

Vesicare

Outcome Measures

Primary Outcome Measures

change of micturition frequency on a 3-day voiding diary [after 12-week treatment]

Secondary Outcome Measures

change in patient's perception of bladder condition [after 12-week treatment]
change in OAB symptom scores [after 12-week treatment]
patient's satisfaction with the treatment [after 12-week treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Daegu	Korea, Republic of	700-712
2	Daegu	Korea, Republic of	705-718
3	Daejon	Korea, Republic of	301-721
4	Inchon	Korea, Republic of	400-711
5	Jeonnam	Korea, Republic of	519-809
6	Pusan	Korea, Republic of	602-739
7	Seoul	Korea, Republic of	135-170
8	Seoul	Korea, Republic of	135-705
9	Seoul	Korea, Republic of	138-736