Overactive Bladder

To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1 mg b.i.d versus placebo in patients with overactive bladder

Uritos

Imidafenacin

Tablet

0.1

Primary endpoint:
To evaluate the change from baseline to week 12 in mean
number of micturition per 24 hrs between the two groups
Secondary endpoints:
(1) Change from baseline to week 12 in mean number of
urge incontinence episodes per 24 hrs between the two
groups.
(2) Change from baseline to week 12 in mean volume voided per micturition between the two groups.
(3) Change from baseline to week 12 in mean number of
urge episodes per 24 hrs between the two groups.
Safety endpoints:
(1) Changes in clinical laboratory examinations, physical
examinations, and vital signs after treatment (from
baseline to each post-treatment visit).
(2) Change in electrocardiograms (ECGs) after treatment
(from baseline to end of treatment visit).
(3) Incidence of adverse events.

Inclusion criteria:
(1) Male or female outpatients ≥ 20 years old.
(2) Overactive bladder symptoms (subject-reported) for ≥ 3
months prior to screening (visit 1).
(3) Reported at least an average of 1 urge incontinence
episode per 24 hours, or ≥ an average of 1 urgency
Protocol No.: Uritos-TW-001
Confidential
Protocol version: v1.0 Page 10 of 62
Date: 30-Mar-2018
episode per 24 hours in the 3-day micturition diary
prior to the randomization/baseline visit (visit 2).
(4) Mean urinary frequency of ≥ 8 micturitions per 24
hours as verified by the micturition diary prior to
randomization/baseline visit (visit 2).
(5) Able and willing to complete the micturition diaries and
comply with scheduled clinic visits and clinical trial
procedures.
(6) Capability of understanding and having signed the
informed consent form after full discussion of the
research nature of the treatment and its risk and
benefits.

Exclusion criteria:
(1) Subjects with current clinical evidence of predominantly genuine stress incontinence, urinary
stone or interstitial cystitis.
(2) Female subjects with bladder outlet obstruction or male subjects diagnosed with bladder outlet obstruction and
benign prostatic hyperplasia who meet any of the conditions below:
 have not been treated with α1-blocker for a duration of at least 3 months and/or 5-α-reductase inhibitor at least 6 months.
 have not recovered from bladder outlet obstruction symptoms.
(3) Subjects with any previous or current malignancies in the genitourinary system.
(4) Any condition that would contraindicate their usage of study drug including: hypersensitivity to the active
substance or to any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma,
myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
(5) Clinically significant hepatic or renal disease, and/or with a screening test of AST, ALT, ALP, urea nitrogen, or
creatinine greater than 1.5 times of the upper limit of normal range (ULN).
(6) Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease confirmed by
imaging tests.
(7) Subjects with current clinical evidences of QT prolongation or at risk of QT prolongation.
(8) History of lower urinary tract surgery (e.g., incontinence surgery or surgery to reduce prostate size
or urethral dilation to treat bladder outlet obstruction) within the past 3 months.
(9) Polyuria (> 3000mL/24h) or a voided volume > 500mL for any micturition during the screening period.
(10) Post-voiding residual volume ≥ 100 mL at the date of screening or randomization.
(11) Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract
infection (r-UTIs) defined as treatment for UTI ≥ 3 times in the last year.
(12) Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence
practitioners) within 4 weeks of visit 1.
(13) Treatment with beta 3-adrenoceptor agonists or antimuscarinic OAB medication within 2 weeks prior to
visit 2; the antimuscarinic OAB medication may include:
darifenacin, oxybutynin, propiverine, solifenacin, tolterodine, fesoterodine or trospium.
(14) Expectation of initiating treatment during the trial with:
Any drug treatment for overactive bladder; Any drugs with significant anticholinergic, or cholinergic agonistic
effects.
(15) Treatment with Botulinum toxin or Hyaluronic acid for bladder syndrome; within 1 year prior to visit 1.
(16) Intermittent or unstable use of diuretics throughout trial duration. Treatment with diuretics initiated within
2 weeks prior to visit 1.
(17) Treatment with strong CYP3A inhibitors, such as azole antifungal agents (e.g., ketoconazole, itraconazole,
miconazole), macrolide antibiotics (erythromycin, clarithromycin), cyclosporine and protease inhibitors, within 2 weeks prior to visit 1 or the expectation to start such a treatment during the trial.
(18) Treatment with strong CYP3A inducers (e.g., barbiturates, rifampicin, carbamazepine, phenytoin,
primidone, or St. John’s Wort) within 2 weeks prior to visit 1, or the expectation to start such a treatment
during the trial.
(19) Treatment with any investigational drug within 30 days prior to visit 1, or the expectation to start such a
treatment during the trial.
(20) Alcohol and/or any other drug abuse including ketamine in the opinion of the investigator.
(21) Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to
become pregnant within 3 months after the completion of the trial.
(22) Female subjects of childbearing potential who are heterosexually active but unwilling or unable to use an
adequate form of contraception to prevent pregnancy during the trial.
(23) Subjects who have any medical (including known history of major hematological, renal, cardiovascular, or
hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to
participate reliably in the trial, or those who may increase the risk to themselves or others by
participating.
(24) Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.