COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSI... | NCT05790902

Studies
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI

NCT05790902

Sponsor

Armed Forces Institute of Urology, Rawalpindi

Status

Completed

Last Update Posted

Mar 30, 2023Actual

Enrollment

142Actual

Phase

Phase 1

Conditions

Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi

Interventions

Silodosin
Tamsulosin

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Feb 28, 2023Actual

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

AJ Arif, DR ABDUL JABBAR ARIF, Armed Forces Institute of Urology, RawalpindiPrincipal Investigator

Lead Sponsor

Armed Forces Institute of Urology, RawalpindiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Silodosin	Drug	The patients used Silodosin for Medical expulsive therapy of ureteric calculi	Silodosin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone clearance rate	Stone clearance rate	upto 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Stone expulsion time	Stone expulsion time	upto 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AFIU Rawalpindi		Rawalpindi	Punjab Province	46000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C095285	silodosin
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided