Lower Ureteral StonesPhase 3NCT06707181
Comparative Study for Medical Therapy for Lower Ureteral Stones
A Phase 3 study testing • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf in people with Lower Ureteral Stones, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are: Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Ureteral Stones
- What is being tested?
- • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 18 Aug 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were adult patients aged 18 years and older with lower ureteral stones measuring 5-10 mm in diameter, diagnosed through imaging techniques such as kidney-ureter-bladder (KUB) x-rays or computed tomography (CT) scans.
Who cannot join
- Exclusion criteria included pregnant and lactating women, renal insufficiency, congenital urinary tract abnormalities, associated kidney stones or contralateral ureteric stones, solitary kidneys, associated infected stones, uncontrolled pain, severe hydronephrosis, history of allergy to the study medications and recent treatment for ureteral stones within the past 3 months (e.g., lithotripsy or surgery) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones
The goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are:
- Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil as a therapy for lower ureteral stones?
- What medical problems do participants have when taking these drugs?
Read more
Researchers will compare silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil to see which drug works better to treat lower ureteral stones Participants will:
- Take silodosin, tamsulosin, silodosin plus tadalafil or tamsulosin plus tadalafil every day for 28 days
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms.
- Conditions
- Lower Ureteral Stones
- Being tested
- • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafDrug
- The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A treated by silodosin 8mg. Receives: Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf |
| Group B | Active comparator | Group B treated by a tamsulosin 0.4 mg . Receives: Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf |
| Group C | Active comparator | Group C was treated with a combination of silodosin 8 mg and tadalafil 5 mg . Receives: Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf |
| Group D | Active comparator | Group D treated by a combination of tamsulosin 0.4 mg and tadalafil 5 mg. Receives: Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Nov 2023
- Primary completion20 May 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Ureteral StonesStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707181
- Sponsor's protocol ID
- M713
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Silodosin , Tamsulosin , Silodosin Plus Tadalafil and Tamsulosin Plus Tadalafil As a Medical Expulsive Therapy for Lower Ureteral Stones
- ClinicalTrials.gov ID
- NCT06707181
- Acronym / sponsor ID
- M713
- Conditions
- Lower Ureteral Stones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 27 Nov 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.
The goal of this clinical trial is to compare the efficacy and adverse effects of different drugs as a medical expulsive therapy for lower ureteral stones. The main questions it aims to answer are:
- Which of the following are more effective silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil as a therapy for lower ureteral stones?
- What medical problems do participants have when taking these drugs?
Researchers will compare silodosin, tamsulosin, silodosin plus tadalafil and tamsulosin plus tadalafil to see which drug works better to treat lower ureteral stones Participants will:
- Take silodosin, tamsulosin, silodosin plus tadalafil or tamsulosin plus tadalafil every day for 28 days
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafGroup A treated by silodosin 8mg. |
| Group B | Active comparator | Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafGroup B treated by a tamsulosin 0.4 mg . |
| Group C | Active comparator | Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafGroup C was treated with a combination of silodosin 8 mg and tadalafil 5 mg . |
| Group D | Active comparator | Drug: • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafGroup D treated by a combination of tamsulosin 0.4 mg and tadalafil 5 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were adult patients aged 18 years and older with lower ureteral stones measuring 5-10 mm in diameter, diagnosed through imaging techniques such as kidney-ureter-bladder (KUB) x-rays or computed tomography (CT) scans.
Key exclusion criteria (1 listed)
- Exclusion criteria included pregnant and lactating women, renal insufficiency, congenital urinary tract abnormalities, associated kidney stones or contralateral ureteric stones, solitary kidneys, associated infected stones, uncontrolled pain, severe hydronephrosis, history of allergy to the study medications and recent treatment for ureteral stones within the past 3 months (e.g., lithotripsy or surgery) .
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 |
|---|---|---|
| • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf• The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalafil 5 mg (Group C) and tamsulosin 0.4 mg plus tadalafil 5 mg (Group D). Drugs are given for a maximal duration of 28 days. | Drug | Group A, Group B, Group C, Group D |
Primary outcome
Expulsion rate
Time frame: 28 days
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 27 Nov 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 3 study testing • The study will include 180 randomly selected patients who met inclusion criteria were randomized into four groups: silodosin 8 mg (Group A), tamsulosin 0.4 mg (Group B), silodosin 8 mg plus tadalaf in people with Lower Ureteral Stones, run by Beni-Suef 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 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 27 Nov 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Expulsion rate (time frame: 28 days). 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 Nov 2024.