NCT05790902

Brief Summary

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_1

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

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 17, 2023

Last Update Submit

March 17, 2023

Conditions

Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi

Outcome Measures

Primary Outcomes (1)

  • Stone clearance rate

    Stone clearance rate

    upto 4 weeks

Secondary Outcomes (1)

  • Stone expulsion time

    upto 4 weeks

Study Arms (2)

Silodosin Group

EXPERIMENTAL

The patients used Silodosin for ureteric calculi

Drug: Silodosin

Tamsulosin Group

EXPERIMENTAL

The patients used Tamsulosin for ureteric calculi

Drug: Tamsulosin

Interventions

SilodosinDRUG

The patients used Silodosin for Medical expulsive therapy of ureteric calculi

Silodosin Group
TamsulosinDRUG

The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi

Tamsulosin Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of \<10 mm in size (on plain CT KUB)

You may not qualify if:

  • solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFIU Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

silodosinTamsulosin

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR ABDUL JABBAR ARIF

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)