overactove bladder MedDRA version: 6.1 Level: PT Classification code 10046494
Conditions
Interventions
Product Code: mk-0954
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0594
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
MERCK SHARP DOHME
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient agrees to participate as indicated by signing the appropriate informed consent. b. Patient is female, aged 40 to 74 years, inclusive, with a history of no menses for at least 1 year and demonstrates serum FSH level equal to or greater than the lower limit of normal for post-menopausal women. Note: Up to 10% patients can be male patients 40 to 74 years of age, inclusive. c. Patient is ambulatory, is in good general physical and mental health, and appears capable of understanding and completing the study procedures including proper completion of the voiding diary. d. History (may be verbal per patient) of urinary urgency for at least 3 months prior to Visit 1. Urodynamic evaluation is NOT required. Visit 2 Criteria e. In the opinion of the investigator, the patient can adequately complete a diary, as assessed by a review of the diary completed during screening. f. The average number of micturitions calculated from the screening diary is ≥8 per diary day. g. The average number of urge incontinence from the screening diary is ≥1 per diary day. h. The total number of urge incontinence episodes exceeds the total number of stress incontinence episodes on the screening diary. Visit 3 Criteria i. In the opinion of the investigator, the patient can adequately complete a diary, as assessed by a review of the completed run-in diary j. The average number of micturitions calculated from the run-in diary is ≥8 per diary day. k. The average number of urge incontinence episodes from the run-in diary is ≥1 per diary day. l. The total number of urge incontinence episodes exceeds the total number of stress incontinence episodes on the run-in diary. 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
Exclusion criteria
Exclusion criteria: General Medical a. Evidence from clinical history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering MK-0594 to the patient, such as mental incompetence, multiple and/or severe allergies, and/or clinically unstable diseases of the cardiovascular, hepatic, renal, gastrointestinal, or hematologic systems that require further medical evaluation and/or treatment. b. Evidence from current history of diabetes insipidus, uncontrolled hyperglycemia (fasting blood glucose >150 mg/dL, and/or non-fasting blood glucose >180 mg/dL) or uncontrolled hypercalcemia (blood total calcium >11 mg/dL). Urologic c. A history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply. d. A history of Lower Urinary Tract Symptoms (LUTS) or Benign Prostatic Hypertrophy (BPH). e. A history of rectal incontinence. f. A history of continual urine leakage or patient is unaware of urine leakage. g. A history of surgery to correct stress urinary incontinence or prolapsed uterus within 6 months. h. Bladder training or electrostimulation within 2 weeks prior to Visit 1 or plans to initiate during the study. i. Active or recurrent (>6 episodes per year) urinary tract infections by clinical history, clinical symptoms, or laboratory criteria (≥5 WBC or ≥20 bacteria per high-powered field in a spun specimen and/or a positive urine culture defined as ≥105 colony forming units (CFU)/mL in 1 specimen). j. Requirement for an indwelling catheter or intermittent catheterization. Medications k. Patient is not willing to discontinue any of the following therapies at least 3 weeks prior to Visit 2 and remain off the therapy for the duration of the study: Anticholinergics including but not limited to oxybutynin, tolterodine, trospium, darafenacin, hyoscyamine, and propantheline. Smooth muscle relaxants including but not limited to flavoxate, dicyclomine, propiverine. l. 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 including but not limited to amitriptyline, imipramine, and doxepin. Seretonin and/or norepinephrine reuptake inhibitors including but not limited to duloxetine. Calcium channel blockers including but not limited to nimodipine and nifedipine. Alpha-adrenergic agonists including but not limited to ephedrine and pseudoephedrine. Diuretic therapy including but not limited to furosemide and hydrochlorothiazide. m. Patient is receiving systemic or topical hormone replacement therapy including but not limited to estrogen and estrogen/progesterone combination products for less than 12 weeks prior to Visit 1 or plans to initiate or change therapy during the study. n. Patient has used any medication with a narrow therapeutic window, including but not limited to warfarin (COUMADIN?, DuPont Pharma) and digoxin within 4 weeks prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: : In patients with overactive bladder (1) To investigate a dose-related reduction in average number of daily micturitions after 8 weeks of treatment with MK-0594 (0.25, 1, or 4 mg/day), compared with placebo. (2) To determine whether there is a lower incidence of dry mouth when treated with MK-0594 compared with tolterodine LA.;Secondary Objective: (3) To determine whether daily treatment with MK-0594 (0.25, 1, or 4 mg/day) reduces the average number of urgency (strong urge to urinate immediately) episodes, total incontinence episodes, and urge incontinence episodes, compared with placebo. (4) To investigate the improvement on exploratory endpoints after treatment with MK-0594 (0.25, 1, or 4 mg/day), compared with placebo. (5) To compare the effect of MK-0594 to tolterodine LA 4 mg on the average number of daily micturitions, urgency (strong urge to urinate immediately) episodes, total incontinence episodes, urge incontinence episodes, and on exploratory1 endpoints over 8 weeks of treatment. (6) To compare the effect of tolterodine LA 4 mg to placebo on the average number of daily micturitions, urgency (strong urge to urinate immediately) episodes, total incontinence episodes, urge incontinence episodes, and on exploratory1 endpoints over 8 weeks of treatment. (7) To determine the tolerability of MK-0594 over 8 weeks;Primary end point(s): : In patients with overactive bladder (1) To investigate a dose-related reduction in average number of daily micturitions after 8 weeks of treatment with MK-0594 (0.25, 1, or 4 mg/day), compared with placebo. (2) To determine whether there is a lower incidence of dry mouth when treated with MK-0594 compared with tolterodine LA. | — |
Countries
Italy
Outcome results
None listed