Lower Ureteric StonesPhase 3NCT06754410
Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study
A Phase 3 study testing Tamsulosin, Cetirizine and Cetirizine + Tamsulosin in people with Lower Ureteric Stones, run by South Valley University at 1 site in Egypt.
Trial summary
we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Ureteric Stones
- What is being tested?
- Tamsulosin, Cetirizine and Cetirizine + Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Mar 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
- all adult patients with lower ureter stone less than 10 mm
Who cannot join
- pregnant, solitary kidney, sensitivity to drugs
Trial locations and contacts
1 site in 1 country.
About this study
we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone
- Conditions
- Lower Ureteric Stones
- Being tested
- Tamsulosin, Cetirizine, Cetirizine + Tamsulosin, Placebo
- Keywords
- stones , ureter, tamsulosin
- Medical subject headings
- Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
group A take tamsulosin once daily
CetirizineDrug
give cetirizine once dailly
Cetirizine + TamsulosinCombination product
both once daily
PlaceboOther
once dailly
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | All patients of group A received tamsulosin 0.4 mg once daily Receives: Drug: Tamsulosin |
| Cetirizine | Active comparator | All patients of group B received Cetirizine once daily Receives: Drug: Cetirizine |
| Cetirizine + Tamsulosin | Active comparator | All patients of group C received Tamsulosin 0.4 mg and Cetirizine once daily Receives: Combination Product: Cetirizine + Tamsulosin |
| Placebo | Placebo comparator | All patients of group D received Placebo once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ureter stone free rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Mar 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Ureteric StonesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa AbdelRazek, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754410
- Sponsor's protocol ID
- SVU.MED.URO016.4.23,5,638
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06754410
- Acronym / sponsor ID
- SVU.MED.URO016.4.23,5,638
- Conditions
- Lower Ureteric Stones
- Keywords
- stones , ureter, tamsulosin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 31 Dec 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.
we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: TamsulosinAll patients of group A received tamsulosin 0.4 mg once daily |
| Cetirizine | Active comparator | Drug: CetirizineAll patients of group B received Cetirizine once daily |
| Cetirizine + Tamsulosin | Active comparator | Combination Product: Cetirizine + TamsulosinAll patients of group C received Tamsulosin 0.4 mg and Cetirizine once daily |
| Placebo | Placebo comparator | Other: PlaceboAll patients of group D received Placebo once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adult patients with lower ureter stone less than 10 mm
Key exclusion criteria (1 listed)
- pregnant, solitary kidney, sensitivity to drugs
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 |
|---|---|---|
| Tamsulosingroup A take tamsulosin once daily | Drug | Tamsulosin |
| Cetirizinegive cetirizine once dailly | Drug | Cetirizine |
| Cetirizine + Tamsulosinboth once daily | Combination product | Cetirizine + Tamsulosin |
| Placeboonce dailly | Other | Placebo |
Primary outcome
ureter stone free rate
Time frame: 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 31 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Lower Ureteric Stones
Recruiting
Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
Ureter Injury, Urolithiasis; Lower Urinary Tract
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 Tamsulosin, Cetirizine and Cetirizine + Tamsulosin in people with Lower Ureteric Stones, run by South Valley 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 31 Dec 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. 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.
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?
ureter stone free rate (time frame: 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 31 Dec 2024.