NCT06754410

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 22, 2024

Last Update Submit

December 22, 2024

Conditions

Lower Ureteric Stones

Keywords

stones , ureter, tamsulosin

Outcome Measures

Primary Outcomes (1)

  • ureter stone free rate

    4 weeks

Study Arms (4)

Tamsulosin

ACTIVE COMPARATOR

All patients of group A received tamsulosin 0.4 mg once daily

Drug: Tamsulosin

Cetirizine

ACTIVE COMPARATOR

All patients of group B received Cetirizine once daily

Drug: Cetirizine

Cetirizine + Tamsulosin

ACTIVE COMPARATOR

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

Combination Product: Cetirizine + Tamsulosin

Placebo

PLACEBO COMPARATOR

All patients of group D received Placebo once daily

Other: Placebo

Interventions

TamsulosinDRUG

group A take tamsulosin once daily

Tamsulosin
CetirizineDRUG

give cetirizine once dailly

Cetirizine
Cetirizine + TamsulosinCOMBINATION_PRODUCT

both once daily

Cetirizine + Tamsulosin
PlaceboOTHER

once dailly

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant, solitary kidney, sensitivity to drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena university hospital

Qina, Qena Governorate, 83523, Egypt

Location

MeSH Terms

Conditions

Calculi

Interventions

TamsulosinCetirizine

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsHydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

December 22, 2024

First Posted

December 31, 2024

Study Start

March 1, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

EG(1)