EUCTR2007-006538-33-CZ进行中（未招募）不适用
A RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED, 5-WAY, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ONO-8539 IN PATIENTS WITH OVERACTIVE BLADDER
Ono Pharmaceutical Co. Ltd.0 个研究点目标入组 440 人开始时间: 2009年1月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 (<20mL/cm H20) within 6 months of Visit 1.
- •2. The patient has any medical condition contraindicating the use of antimuscarinic medication
- •3. The patient has a history of malignancy within the past 5 years of the screening visit.However, patients who have been adequately treated within the past 5 years for their basal cell or squamous carcinoma of the skin are not excluded.
- •4. The patient has a medical history of :
- •a. Liver disease
- •b. Acromegaly or treatment with growth hormone or similar drugs
- •c. Major gastrointestinal surgery
- •5. The patient has one of the following cardiovascular conditions:
- •a. Angina. However, patients who are well controlled on their regular medication with no clinical symptoms or those patients who require occasional nitrates, such as nitroglycerin on exertion, are not excluded.
- •b. Congestive heart failure (CHF) with symptoms that occur at rest or minimal activity
- •c. History of myocardial infarction within the past 6 months of sceening visit
- •d. Coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months of screening visit
- •e. Abnormal blood pressure.
- •Note: subjects with medically controlled blood pressure (stable for at least three months) may participate
- •f. QTc interval (corrected by the Frederica formula: i.e. QTcF) is > 450 msec for male patients and > 470msec 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 screen
研究者
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