A Phase IIb Clinical Study of the Efficacy and Satefy of MK-4618 in Patients with Overactive Bladder
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000316
- Lead Sponsor
- MSD Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 41
If female, must be of non-childbearing potential
-If male of reproductive potential, must agree to remain abstinent or use (or have his partner use) 2 acceptable methods of birth control within the projected duration of the study
-Has a clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria
-Is able to read, understand and complete questionnaires and voiding diaries by herself/himself
-Is ambulatory and in good general physical and mental health
-Has no clinically significant electrocardiogram or laboratory abnormality
-Has evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia
-Has an allergy, intolerance, or has a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or MK-4618 formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label
-Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence
-Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply
-Has a history of continual urine leakage
-Has had surgery to correct stress urinary incontinence or prolapsed uterus within 6 months
-Has a known history of elevated postvoid residual
-Has undergone bladder training or electrostimulation within 2 weeks or plans to initiate either during the study
-Has active or recurrent (>6 episodes per year) urinary tract infections
-Has hematuria
-Has a requirement for an indwelling catheter or intermittent catheterization
-Has a history of fecal incontinence
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate a dose-related reduction in average number of daily micturitions compared with placebo at Week 8;To assess the safety and tolerability of treatment with the selected MK-4618 doses either alone or dosed concomitantly with tolterodine ER
- Secondary Outcome Measures
Name Time Method To assess the effect of MK-4618 compared with placebo on: the average number of urge incontinence in OAB wet, the average number of total incontinence in OAB wet, the average number of strong urge;To investigate whether there is a lower incidence of dry mouth when treated with MK-4618 compared with tolterodine ER;The effect of concomitant dosing (MK-4618 and tolterodine ER) compared with the effect of the selected dose of MK-4618 monotherapy and of tolterodine ER monotherapy on the number of daily micturition