TamsulosinNCT05759767
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
A study testing Tamsulosin in people with Tamsulosin and Extracorporeal Shock Wave Lithotripsy, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Dec 2023
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
- Normal kidney function.
Who cannot join
- Bleeding diatheses
- Uncontrolled UTIs
- Severe skeletal malformations
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.
- Conditions
- Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney, Stone, Urinary, Pediatric Disorder
- Being tested
- Tamsulosin, Placebo
- Keywords
- Extracorporeal Shock Wave Lithotripsy, tamsulosin
- Medical subject headings
- Kidney Calculi, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.
PlaceboDrug
Children in this group will receive placebo once daily for 3 weeks after ESWL session.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session. Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | Children in this group will receive Placebo for 3 weeks after ESWL session. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the Stone-free rate (SFR) between groups
SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TamsulosinStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759767
- Sponsor's protocol ID
- Ped MET SWL
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 10 Mar 2023
- 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 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
- ClinicalTrials.gov ID
- NCT05759767
- Acronym / sponsor ID
- Ped MET SWL
- Conditions
- Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney, Stone, Urinary, Pediatric Disorder
- Keywords
- Extracorporeal Shock Wave Lithotripsy, tamsulosin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 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.
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: TamsulosinChildren in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session. |
| Placebo | Placebo comparator | Drug: PlaceboChildren in this group will receive Placebo for 3 weeks after ESWL session. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
- Normal kidney function.
Key exclusion criteria (3 listed)
- Bleeding diatheses
- Uncontrolled UTIs
- Severe skeletal malformations
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 |
|---|---|---|
| TamsulosinChildren in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session. | Drug | Tamsulosin |
| PlaceboChildren in this group will receive placebo once daily for 3 weeks after ESWL session. | Drug | Placebo |
Primary outcome
assess the Stone-free rate (SFR) between groups
Time frame: three months
SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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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 study testing Tamsulosin in people with Tamsulosin and Extracorporeal Shock Wave Lithotripsy, run by Mansoura University at 1 site in Egypt.
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 3 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 10 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
assess the Stone-free rate (SFR) between groups (time frame: three months). 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 10 Mar 2023.