A 52 Week extension to: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder - PhIIb Dose Ranging Study
- Conditions
- Overactive BladderMedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
- Registration Number
- EUCTR2010-022121-15-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1395
Base study:
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 the 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 (averages should not be rounded up to the whole number):
• OAB wet criteria: An average of =8.0 micturitions 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.
Or
•OAB dry criteria: An average of =8.0 micturitions per diary day; and,
an average of =3.0 strong urge episodes per diary day; and an average of < 1.0 urge incontinence episode 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.
52 week extension:
Patient completed either Part 1 or Part 2 of the base study.
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
Base study:
1.Patient has 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 has a history of cerebral vascular accident, transient ischemic attack, unstable angina, or myocardial infarction within the previous 6 months.
4.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.
5.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.
6.Patient has a history of continual urine leakage or patient is unaware of urine leakage.
7. Patient has a history of surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months.
8.Patient has a known history of elevated postvoid residual defined per the investigator's local standard of care.
9.Patient has undergone bladder training or electrostimulation within 2 weeks prior to Visit 1 or plans to initiate either during the study.
10.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.
11.Patient has hematuria, including microscopic hematuria (> 5 RBCs/hpf).
12.Patient has a requirement for an indwelling catheter or intermittent catheterization.
13.Patient has a history of fecal incontinence.
14.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
•Smooth muscle relaxants
•Beta 2 adrenergic agonists used for the treatment of stress urinary incontinence
•Synthetic antidiuretic hormones
•Phosphodiesterase type 5 (PDE 5) inhibitors, including but not limited to tadalafil, sidenafil and vardenafil.
• Beta 3 adrenergic agonists, including but not limited to mirabegron.
15. Patient is receiving therapy with any of the following medications for less than 8 weeks prior to Visit 1 or plans to initiate or change therapy during the study.
• Tricyclic antidepressants or combinations
• Serotonin and/or norepinephrine reuptake inhibitors
• Alpha-adrenergic agonists, including nonspecific sympathomimetic amines
• Diuretic therapy
• Hormone repla
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