2-Part Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder
- Conditions
- Overactive BladderMedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 10038359 - Renal and urinary disorders
- Registration Number
- EUCTR2010-022121-15-NO
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1395
1.Patient is male or female between 18 and 75 years of age inclusive on day of signing informed consent.
2. A female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within th projected duration of the study.
3.Patient has a clinical history of OAB (may be verbal per patient) for at least 3 months prior to Visit 1. OAB is defined as urgency, with or without urge incontinence, usually associated with frequency and nocturia. Urodynamic evaluation is not required.
4.Patient is able to read, understand and complete questionnaires and voiding diaries as well as collect, measure and record voided volume by herself/himself using a graduated beaker and toilet seat hat (if needed), which will be provided by the SPONSOR.
5.Patient meets either the OAB wet or OAB dry (patients with no or minimal incontinence of any type) criteria described below based on the screening diary returned at Visit 2 and the placebo run-in diary returned at Visit 3:
•OAB wet criteria: An average of = 8.0 micturitions per diary day and an average of = 1.0 urge incontinence episodes per diary, and total number of urge incontinence episodes must be greater than the total number of stress incontinence episodes from the screening diary / run-in diary.
OR
•OAB dry criteria: An average of = 8.0 micturitions per diary; and an average of = 3.0 strong urge episodes per diary day; and an average of <1.0 urge incontinence episodes per diary day; and the total number of urge incontinence episodes must be greater than the total number of stress incontinence episodes from the screening diary / run-in diary.
Note: Patients should be randomized to either the OAB wet or OAB dry stratum based on criteria met at Visit 3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patient has the following laboratory parameters: evidence of diabetes insipidus, uncontrolled hyperglycemia (fasting blood glucose >150 mg/dL or 8.33 mmol/l and/or non fasting blood glucose >180 mg/dL or 10.0 mmol/l), or uncontrolled hypercalcemia (blood total calcium >11 mg/dL or 2.75 mmol/l).
2.Patient has a resting systolic blood pressure > 160 mmHg or resting diastolic blood pressure >90 mmHg or resting heart rate (by pulse) > 100 beats per minute at Visit 1.
3.Patient is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
4.Patient has a history of cerebral vascular accident, transient ischemic attack, unstable angina, or myocardial infarction within the previous 6 months.
5.Patient has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence; including but not limited to urolithiasis, interstitial cystitis, urothelial tumor, prostatitis, and clinically relevant benign prostatic hypertrophy or bladder outlet obstruction as judged by the investigator.
6.Patient has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply.
7.Patient has a history of continual urine leakage or patient is unaware of urine leakage.
8.Patient has a history of surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months.
9.Patient has a known history of elevated postvoid residual defined per the investigator's local standard of care.
10.Patient has undergone bladder training or electrostimulation within 2 weeks prior to Visit 1 or plans to initiate either during the study.
11.Patient has active or recurrent (>6 episodes per year) urinary tract infections by clinical history, clinical symptoms, or laboratory criteria (= 5 WBC or = 26 bacteria (moderate) per high-powered field in a spun specimen and/or a positive urine culture defined as = 104 colony forming units (CFU)/mL in 1 specimen.
12.Patient has hematuria, including microscopic hematuria (> 5 RBCs/hpf).
13.Patient has a requirement for an indwelling catheter or intermittent catheterization.
14.Patient has a history of fecal incontinence.
15.Patient is not willing to discontinue use of the following therapies at least 2 weeks prior to completing the screening voiding diary and remain off these therapies for the duration of the study:
•Anticholinergics including but not limited to oxybutynin, tolterodine, trospium, darifenacin, solifenacin, fesoterodine, hyoscyamine, and propantheline.
•Smooth muscle relaxants including but not limited to flavoxate, dicyclomine, propiverine.
•Beta 2 adrenergic agonists used for the treatment of stress urinary incontinence including but not limited to clenbuterol.
•Synthetic antidiuretic hormones, including but not limited to desmopressin.
•Phosphodiesterase type 5 (PDE 5) inhibitors, including but not limited to tadalafil, sildafil and vardenafil.
•Beta 3 adrenergic aginists, including but not limited to mirabegron.
16.Patient is receiving therapy with any of
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method