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CompletedNCT06754410Updated Dec 31, 2024

Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study

A Phase 3 interventional study of Tamsulosin and Cetirizine in Lower Ureteric Stones, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by South Valley University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone

02

Conditions studied

  • Lower Ureteric Stones

Keywords

  • stones , ureter, tamsulosin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all adult patients with lower ureter stone less than 10 mm

Exclusion criteria

Exclusion Criteria:

  • pregnant, solitary kidney, sensitivity to drugs
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
480 participants (actual)

Study arms

  • Active comparator
    Tamsulosin

    All patients of group A received tamsulosin 0.4 mg once daily

    Drug: Tamsulosin

  • Active comparator
    Cetirizine

    All patients of group B received Cetirizine once daily

    Drug: Cetirizine

  • Active comparator
    Cetirizine + Tamsulosin

    All patients of group C received Tamsulosin 0.4 mg and Cetirizine once daily

    Combination Product: Cetirizine + Tamsulosin

  • Placebo comparator
    Placebo

    All patients of group D received Placebo once daily

    Other: Placebo

Interventions

  • DrugTamsulosin

    group A take tamsulosin once daily

  • DrugCetirizine

    give cetirizine once dailly

  • Combination productCetirizine + Tamsulosin

    both once daily

  • OtherPlacebo

    once dailly

05

What researchers measure

Primary outcomes

  1. ureter stone free rate

    Time frame: 4 weeks

06

Study locations

1 site
  • Qena university hospital
    Qena, 83523, Egypt
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06754410
Lead sponsor
South Valley University
Responsible party
Mostafa AbdelRazek (Assistant Professor of Urology, South Valley University) — Principal investigator
First posted
Dec 31, 2024
Start date
Mar 1, 2021
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Last update
Dec 31, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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