Overactive bladder MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: ONO-8539 Tablets
Product Code: ONO-8539
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: 4-[({6-[Isobutyl(1,3-thiazol-2-ylsulfonyl)amino]- 2,3-dihydro-1H-inden-5-yl}oxy)methy
Sponsors
Ono Pharmaceutical Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged between 18 and 80 years old inclusive 2.Patients have overactive bladder as defined by the standardization subcommittee of the International Continence Society (ICS) as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local pathological or metabolic factors for >= 6 months. 3.During the placebo run-in, patients will have demonstrated: a. Urinary frequency defined as at least 8 micturitions per 24 hrs on each diary day of the 3-day diary period and b. Urinary urgency defined as at least 1 episode per 24hrs on each diary day and at least 6 episodes per 72 hrs of the 3-day diary period. ‘Urgency’ is defined as the event of grade 3 (Severe urgency) or grade 4 (urge incontinence) using the Patient Perception of Intensity of Urgency Scales (PPIUS); or c. Urinary urgency incontinence defined as at least 1 urgency incontinence episode (involuntary loss of urine associated with urgency) per 24 hrs on each diary day of the 3-day diary period. ‘Urinary urgency incontinence’ is defined as the event of grade 4 (urge incontinence) using the PPIUS. 4. If male, patients must agree for themselves or their partner to use an adequate method of contraception from Visit 1 until 1 month after their follow up study visit. 5. If female, the patient must be post-menopausal, sterile or practice adequate contraception whenever sexually active for a period of at least 28 days before Visit 1 and agree to use a double barrier method to prevent pregnancy from Visit 1 until at least 1 month after the follow up visit. 6. The patient is able to read and understand the Patient Information Sheet and study procedures 7. The patient is able and willing to give written informed consent. 8. The patient must be at least 80% compliant with the drug dosing during the 2 weeks of placebo-run-in phase 9. The patient is capable of independently completing the bladder 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: 1. The patient has the following pathological or metabolic conditions that may be the responsible for urgency or incontinence: a. Stress incontinence or mixed incontinence where stress incontinence is the predominant component b. Require in dwelling (intermittent) catheter c. Genitourinary conditions other than overactive bladder that may cause urinary incontinence or affect urinary frequency d. History of interstitial cystitis, pelvic or perineal pain, or haematuria that has not been evaluated to rule out malignant diseases within 12 months of Visit 1 e. Undergone electrostimulation therapy or bladder training within 14 days of the screening visit or are planning to do so during the study period f. Undergone prostate surgery within the last 12 months of Visit 1 or had any type of operative procedure for urinary incontinence, or anterior colporrhaphy within the last 12 months of Visit 1 g. Past history of, or current neurological disease or injury that could affect the lower urinary tract function or its nerve supply h. Requirement for ambulatory assistance or incapable of independent toileting i. Difficulty emptying the bladder, or history of obstructive uropathy or urinary retention j. Residual urine volume of >200 mL k. Bladder outlet obstruction l. Polyuria defined as total voided urine volume of >3000 ml on at least one day (24 h) (within the 3-day diary period) m. Clinically suspected low bladder compliance or patient has an urodynamics evidence of low bladder compliance ( 450 msec for male patients and >470 msec for female patients on 12-lead ECG prior to randomisation visit. 6. The patient has a history of and/or current alcoholism or drug abuse (within the past 2 years) 7. The patient has a history or presence of other significant diseases, which might compromise the patient’s safety or the evaluation of the study results 8. The patient has acute gastrointestinal symptoms, except constipation, within 14 days of Visit 1 9. The patient has undergone botulinum toxin detrusor injection and vanilloids drugs within 12 months of Visit 1 10. The patient has taken any prohibited concomitant medication (as per study protocol) within the defined period prior to scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24h from baseline to 12 weeks;Primary end point(s): The mean change from baseline in the number of micturitions per 24 hrs at 12 weeks.;Secondary Objective: •To compare the effect of three different doses of ONO-8539 and Tolterodine versus placebo on the number of micturitions per 24h, frequency of urinary urgency incontinence episodes per 24h, number of urgency episodes per 24h, severity of urgency, mean volume voided per micturition, number of micturitions during daytime, number of micturitions during sleeping time and number of continent days (among incontinent patients), during the course of treatment; •To compare the effect of three different doses of ONO-8539 and Tolterodine versus placebo on subjective scales of treatment effect and Quality of Life, during the course of treatment; •To compare the safety and tolerability of three different doses of ONO-8539 and Tolterodine versus placebo | — |
Countries
Czech Republic, Hungary, Netherlands, Sweden
Outcome results
None listed