A comparative study of ZG-802 and placebo in patients with underactive bladder

JRCT ID: jRCT2071230011

Registered date:29/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Underactive bladder
• Date of first enrollment: 12/07/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Subjects are randomly assigned to the ZG-802 dose A group, ZG-802 dose B group, or placebo group, and orally administered three times a day before each meal for 12 weeks. The visit for this study was set once every 2 to 4 weeks.

Outcome(s)

• Primary Outcome: Change in post-void residual from baseline to week 12
• Secondary Outcome: Change in Post-void residual, Change in Bladder voiding efficiency

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have any symptoms of slow stream, hesitancy or straining to void for more than 90 days before the Screening date
2) Patients who meet all the specified criteria of uroflowmetry and transabdominal ultrasonographya for both Screening and Baseline
3) 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
4) Patients aged 18 years or older at the time of informed consent

Exclude criteria

1) Patients with a urgency score of 2 or more on the Overactive Bladder Symptom Questionnaire during the observation period
2) 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
3) Patients with urethral diverticulum or extremely large bladder diverticulum
4) Patients with ureteral calculus, vesical calculus or urethral calculus
5) Patients with progressive neurodegenerative disease (e.g. Parkinson's disease, multiple system atrophy, progressive supranuclear palsy)
6) 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)
7) Patients with increased pelvic floor muscle activity during urination (e.g., striated sphincter incoordination, Fowler's syndrome, pelvic floor muscle spasms)
8) Patients with or suspected of having a symptomatic urinary tract infection or genital infection
9) Patients with severe urinary organ pain
10) 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
11) 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
12) Patients who are encouraged to urinate by applying pressure from outside the body such as the Crede's procedure, valsalva maneuver or by tapping
13) 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)
14) Patients judged by the investigator to be unable to properly record the bladder diary of Baseline
15) 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
16) Patients with clinically significant heart disease, liver disease, renal disease, blood disease, etc.
17) Patients with allergy to certain chemical substances
18) 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.
19) 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.
20) 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
21) Patients who are hospitalized during the observation period, or who are scheduled to be hospitalized during the treatment period
22) Other patients who are deemed inappropriate for participation in this study by the investigator

Related Information

• Primary Sponsor: Tomioka Yusuke