jRCT2071230011招募中不适用
ZG-802 Phase IIa Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-802 in patients with Underactive Bladder -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who have any symptoms of slow stream, hesitancy or straining to void for more than 90 days before the Screening date
- •Patients who meet all the specified criteria of uroflowmetry and transabdominal ultrasonographya for both Screening and Baseline
- •Patients with a score of specified points or more in any item of voiding symptoms (intermittency, slow stream and straining to void) of the International Prostate Symptom Score for Baseline
- •Patients aged 18 years or older at the time of informed consent
排除标准
- •Patients with a urgency score of 2 or more on the Overactive Bladder Symptom Questionnaire during the observation period
- •Patients with bladder outlet obstruction who meet one or more of the following
- •a) Female patients with pelvic organ prolapse of stage III or higher in the POP - Q stage classification
- •b) Male patients with Intravesical prostatic protrusion >= 10 mm
- •c) Male patient with prostate cancer
- •d) Patients with severe urethral stricture requiring surgery
- •e) Patients who do not fall under a) to d) but are judged by investigators to have a clinically problematic bladder outlet obstruction
- •Patients with urethral diverticulum or extremely large bladder diverticulum
- •Patients with ureteral calculus, vesical calculus or urethral calculus
- •Patients with progressive neurodegenerative disease (e.g. Parkinson's disease, multiple system atrophy, progressive supranuclear palsy)
- •Patients with neurological diseases other than progressive neurodegenerative diseases who show a clear exacerbation or recovery tendency (e.g., cerebrovascular disease, normal pressure hydrocephalus, cerebral white matter lesion, spinal cord injury, multiple sclerosis) , vascular disease of spinal cord, lumbar diseases (spinal canal stenosis, degenerative spondylolisthesis, lumber vertebrae herniated disk, etc.), diabetic neuropathy)
- •Patients with increased pelvic floor muscle activity during urination (e.g., striated sphincter incoordination, Fowler's syndrome, pelvic floor muscle spasms)
- •Patients with or suspected of having a symptomatic urinary tract infection or genital infection
- •Patients with severe urinary organ pain
- •Patients who have recieved certain treatments, patients who have been treated within certain period, or patients who are expected to be treated them during the treatment period
- •Patients who have changed the dosage and administration of certain drugs within certain period, or patients who are expected to change during the treatment period
- •Patients who are encouraged to urinate by applying pressure from outside the body such as the Crede's procedure, valsalva maneuver or by tapping
- •Patients with a history of surgery for the lower urinary tract, prostate, or pelvic organ prolapse, or expected to be performed during the treatment period (However, patients may be included if the surgery was performed more than 180 days prior to the screening date and the investigator judges that the patient was free of urethral stricture or urethral obstruction as of the baseline date)
- •Patients judged by the investigator to be unable to properly record the bladder diary of Baseline
- •Patients who have used other investigational drugs within the past 30 days including the screening date, or patients whose period between the time of use of other investigational drugs and the screening date is within 5 times the half-life of the relevant investigational drug
- •Patients with clinically significant heart disease, liver disease, renal disease, blood disease, etc.
- •Patients with allergy to certain chemical substances
- •Patients with malignant tumors. Patients who have been treated for malignant tumors or have had a malignant tumor, in the past 5 years including the baseline date.
- •Female patients who are pregnant or breastfeeding. Male patients and premenopausal female patients who are unable to use adequate contraception during the study period and for 7 days after the end of study drug administration.
- •Patients with a history of acute alcohol intoxication or alcohol dependence within the past 1 year including the baseline date, or patients with a history of drug and chemical substance abuse in the past
- •Patients who are hospitalized during the observation period, or who are scheduled to be hospitalized during the treatment period
- •Other patients who are deemed inappropriate for participation in this study by the investigator
结局指标
主要结局
-
Change in post-void residual from baseline to week 12
次要结局
未报告次要终点
研究者
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