Stone, KidneyPhase 1/2NCT06381206
Silodosin in Management of Lower Ureteral Stones
A Phase 1/2 study testing Silodosin in people with Stone, Kidney, run by Syrian Private University at 1 site in Syria.
Trial summary
This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- Silodosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSyria
- Study dates
- 20 Oct 2022to 25 Oct 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter.
Who cannot join
- Patients under 18 years of age
- Pregnant women
- Patients with whom we were unable to contact
- Patients treated with silodosin for another reason
- Single kidney patients
- Patients with bilateral ureter stones
- Patients with deteriorating kidney function
- Patients with grades 3rd and 4th of hydronephrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Selective Alpha Blockers (Silodosin) in Management of Lower Ureteral Stones Larger Than 6 mm in Diameter
This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin.
- Conditions
- Stone, Kidney
- Being tested
- Silodosin
- Keywords
- Silodosin, Lower Ureteral, Ureteral Stones
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Selective Alpha Blocker drug
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | patients who had given silodosin Receives: Drug: Silodosin |
| Control group | No intervention | patients who had not given silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone expulsion (yes)
patients who were able to expel the stone
Measured: 1 year
Stone expulsion (no)
patients who were not able to expel the stone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start20 Oct 2022
- Primary completion20 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syrian Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Haj Ali, Syrian Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381206
- Sponsor's protocol ID
- No 475
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Selective Alpha Blockers (Silodosin) in Management of Lower Ureteral Stones Larger Than 6 mm in Diameter
- ClinicalTrials.gov ID
- NCT06381206
- Acronym / sponsor ID
- No 475
- Conditions
- Stone, Kidney
- Keywords
- Silodosin, Lower Ureteral, Ureteral Stones
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Syrian Private UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 24 Apr 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.
This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Drug: Silodosinpatients who had given silodosin |
| Control group | No intervention | –patients who had not given silodosin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter.
Key exclusion criteria (8 listed)
- Patients under 18 years of age
- Pregnant women
- Patients with whom we were unable to contact
- Patients treated with silodosin for another reason
- Single kidney patients
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 |
|---|---|---|
| SilodosinSelective Alpha Blocker drug | Drug | case group |
Primary outcome
Stone expulsion (yes)
Time frame: 1 year
patients who were able to expel the stone
Stone expulsion (no)
Time frame: 1 year
patients who were not able to expel the stone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Silodosin in people with Stone, Kidney, run by Syrian Private University at 1 site in Syria.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 24 Apr 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 Syria. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone expulsion (yes) (time frame: 1 year). 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 24 Apr 2024.