Status:
COMPLETED
Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Urinary Bladder, Overactive
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00979472
Start Date
April 1 2009
End Date
June 1 2010
Last Update
February 2 2016
Active Locations (9)
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1
Daegu, South Korea, 700-712
2
Daegu, South Korea, 705-718
3
Daejeon, South Korea, 301-721
4
Inchon, South Korea, 400-711