Human TrichinellosisNCT06332235
Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.
An observational study of Human Trichinellosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Human Trichinellosis
- What is being tested?
- Silodosin 8 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed of acute brain injury with Foley insertion with 5 days
Who may be able to join
- Subject ≥ 20 years of age
- Newly diagnosed of acute brain injury with Foley insertion with 5 days
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin District, 807
Chen Yu Chen, MS, 0911884597, jennis7995@hotmail.com
About this study
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.
To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.
Read the 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.
- Conditions
- Human Trichinellosis
- Being tested
- Silodosin 8 mg
- Medical subject headings
- Trichinellosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silodosin 8 mgDrug
Also called Conventional treatment
Dosing schedule: Oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | 1. Subject ≥ 20 years of age
2. Newly diagnosed of acute brain injury with Foley insertion with 5 days Receives: Drug: Silodosin 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment criteria Efficacy
Efficacy: the rate of Foley removal
Measured: 56 day
Assessment criteria Safety
Silodosin-related adverse events
Measured: 56 day
Secondary outcomes (1)
Assessment criteria Efficacy
Efficacy: the rate of urinary tract infection
Measured: 56 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Feb 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human TrichinellosisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IRB, Study chair, Affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332235
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220023
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06332235
- Acronym / sponsor ID
- KMUHIRB-F(I)-20220023
- Conditions
- Human Trichinellosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | – | Drug: Silodosin 8 mg1. Subject ≥ 20 years of age 2. Newly diagnosed of acute brain injury with Foley insertion with 5 days |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed of acute brain injury with Foley insertion with 5 days
Key inclusion criteria (2 listed)
- Subject ≥ 20 years of age
- Newly diagnosed of acute brain injury with Foley insertion with 5 days
Key exclusion criteria (10 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silodosin 8 mgAlso: Conventional treatmentDosing schedule: Oral, once daily | Drug | Experiment group |
Primary outcome
Assessment criteria Efficacy
Time frame: 56 day
Efficacy: the rate of Foley removal
Assessment criteria Safety
Time frame: 56 day
Silodosin-related adverse events
1 secondary outcome
Assessment criteria Efficacy
Time frame: 56 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRB study chair
Affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Trichinellosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Yu Chen, MS (0911884597, jennis7995@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment criteria Efficacy (time frame: 56 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.