Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric CalculiPhase 1NCT05790902
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
A Phase 1 study testing Silodosin and Tamsulosin in people with Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
Trial summary
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
- What is being tested?
- Silodosin and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 28 Feb 2023
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of <10 mm in size (on plain CT KUB)
Who cannot join
- solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
Trial locations and contacts
1 site in 1 country.
About this study
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.
Read the detailed description
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.
- Being tested
- Silodosin, Tamsulosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
The patients used Silodosin for Medical expulsive therapy of ureteric calculi
TamsulosinDrug
The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi
| Study group | Role | What they receive |
|---|---|---|
| Silodosin Group | Experimental | The patients used Silodosin for ureteric calculi Receives: Drug: Silodosin |
| Tamsulosin Group | Experimental | The patients used Tamsulosin for ureteric calculi Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance rate
Stone clearance rate
Measured: upto 4 weeks
Secondary outcomes (1)
Stone expulsion time
Stone expulsion time
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric CalculiStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Urology, Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AJ Arif, Armed Forces Institute of Urology, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790902
- Sponsor's protocol ID
- AFIU-2022-02
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
- ClinicalTrials.gov ID
- NCT05790902
- Acronym / sponsor ID
- AFIU-2022-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Armed Forces Institute of Urology, RawalpindiUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 30 Mar 2023 (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 compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.
Detailed description
to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin Group | Experimental | Drug: SilodosinThe patients used Silodosin for ureteric calculi |
| Tamsulosin Group | Experimental | Drug: TamsulosinThe patients used Tamsulosin for ureteric calculi |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of <10 mm in size (on plain CT KUB)
Key exclusion criteria (1 listed)
- solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
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 |
|---|---|---|
| SilodosinThe patients used Silodosin for Medical expulsive therapy of ureteric calculi | Drug | Silodosin Group |
| TamsulosinThe patients used Tamsulosin for Medical expulsive therapy of ureteric calculi | Drug | Tamsulosin Group |
Primary outcome
Stone clearance rate
Time frame: upto 4 weeks
Stone clearance rate
1 secondary outcome
Stone expulsion time
Time frame: upto 4 weeks
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 30 Mar 2023.
- Individual participant dataSharing planned: No
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 study testing Silodosin and Tamsulosin in people with Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
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 1 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 30 Mar 2023. 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 Pakistan. 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 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.
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 clearance rate (time frame: upto 4 weeks). 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 30 Mar 2023.