Efficacy and Safety of Silodosin in the Treatment of Lowe... | NCT06332235

Studies
Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.

NCT06332235

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

Mar 27, 2024Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Human Trichinellosis

Interventions

Silodosin 8 mg

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2022Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 9, 2023

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Name: Silodosin 8mg/capsule
Dosage form: capsule (Silodosin)
Dose(s): 8mg
Dosing schedule: Oral, once daily
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experiment group		Subject ≥ 20 years of age Newly diagnosed of acute brain injury with Foley insertion with 5 days	Drug: Silodosin 8 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silodosin 8 mg	Drug	Dosing schedule: Oral, once daily	Experiment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment criteria Efficacy	Efficacy: the rate of Foley removal	56 day
Assessment criteria Safety	Silodosin-related adverse events	56 day

Secondary Outcomes

Measure	Description	Time Frame
Assessment criteria Efficacy	Efficacy: the rate of urinary tract infection	56 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject ≥ 20 years of age
Newly diagnosed of acute brain injury with Foley insertion with 5 days

Exclusion Criteria:

Subjects with already in use of α1A-adrenergic receptor blocker used
Subjects with urethral trauma
Subjects with a history of prostate, penile, testicular, bladder, or urethral cancer or has received pelvic radiation, systemic chemotherapy, or intravesical chemotherapy
Expected survival days for brain injury less than 28 days
Subjects with a history of renal dysfunction (elevated creatinine (>2.0 mg/dL))
Subjects with severe liver impairment (Child-Pugh score≧10)
Subjects with CYP3A4 inhibitors (ketoconazole、clarithromycin、itraconazole、ritonavir) used
Subjects with pregnancy
Subject who has been in an investigational drug study in the past 3 months
Subjects who is considered as ineligible for participation in this clinical study by the principle investigator or the co-investigator's judgement.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed of acute brain injury with Foley insertion with 5 days

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen Yu Chen, MS	Contact	0911884597		jennis7995@hotmail.com

Overall Officials

Name	Affiliation	Role
IRB	Affiliation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Memorial Hospital	Recruiting	Kaohsiung City	Sanmin District	807	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D014235	Trichinellosis

Ancestor Terms

ID	Term
D017189	Enoplida Infections
D017188	Adenophorea Infections
D009349	Nematode Infections
D006373	Helminthiasis

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