Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT06332235
Status:
UNKNOWN
Last Update Posted:
2024-03-27
First Post:
2023-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Study Overview
Official Title:
A Randomized Open Label Phase-II Control Trial to Evaluate the Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.
Detailed Description:
I.Test drug
1. Name: Silodosin 8mg/capsule
2. Dosage form: capsule (Silodosin)
3. Dose(s): 8mg
4. Dosing schedule: Oral, once daily
5. Mechanism of action: Silodosin blocks the α1A-adrenergic receptors in the prostate gland and urethra, causing smooth muscle relaxation. Since the intraurethral pressure of the urethra is reduced, urine can pass more easily and the urinary symptoms are relieved.
6. Pharmacological category: α1A-adrenergic receptor blocker
II.The process of the experiment (brief describe) Eligible subjects will be randomized to a study medication according to the randomization schedule (a 1:1 randomization ratio). There are 2 groups in this study, with group A (treatment group, silodosin 8mg, once daily, 8-week duration) and group B (control group).
III. The primary endpoint is the rate of Foley removal. The secondary endpoints are the rate of urinary tract infection, residual urine amount and the rate of re-on Foley.
1. Name: Silodosin 8mg/capsule
2. Dosage form: capsule (Silodosin)
3. Dose(s): 8mg
4. Dosing schedule: Oral, once daily
5. Mechanism of action: Silodosin blocks the α1A-adrenergic receptors in the prostate gland and urethra, causing smooth muscle relaxation. Since the intraurethral pressure of the urethra is reduced, urine can pass more easily and the urinary symptoms are relieved.
6. Pharmacological category: α1A-adrenergic receptor blocker
II.The process of the experiment (brief describe) Eligible subjects will be randomized to a study medication according to the randomization schedule (a 1:1 randomization ratio). There are 2 groups in this study, with group A (treatment group, silodosin 8mg, once daily, 8-week duration) and group B (control group).
III. The primary endpoint is the rate of Foley removal. The secondary endpoints are the rate of urinary tract infection, residual urine amount and the rate of re-on Foley.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: