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The efficacy and safety of observation therapy or terazosin 2mg or 5mg administration for Distal Ureter Stone patients

Status Approved

First Submitted Date

2020/04/22
Registered Date

2020/05/22
Last Updated Date

2020/04/22

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005052
Unique Protocol ID	2020-02-001
Public/Brief Title	The efficacy and safety of observation therapy or terazosin 2mg or 5mg administration for Distal Ureter Stone Patients
Scientific Title	The efficacy and safety of observation therapy or terazosin 2mg or 5mg administration for Distal Ureter Stone patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SEOUL-2020-02-001-002
Approval Date	2020-04-09
Institutional Review Board Name	Seoul medical Center Institutional Review Board
Institutional Review Board Address	156, Sinnae-ro, Jungnang-gu, Seoul
Institutional Review Board Telephone	02-2276-7433
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Choi Seung kwon
Title	section chief
Telephone	+82-2-2276-7853
Affiliation	Seoul Medical Center
Address	156, Sinnae-ro, Jungnang-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Choi Seung kwon
Title	section chief
Telephone	+82-2-2276-7853
Affiliation	Seoul Medical Center
Address	156, Sinnae-ro, Jungnang-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Choi Seung kwon
Title	section chief
Telephone	+82-2-2276-7853
Affiliation	Seoul Medical Center
Address	156, Sinnae-ro, Jungnang-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-07-02 Anticipated
Target Number of Participant	194
Primary Completion Date	2021-12-30 , Anticipated
Study Completion Date	2022-02-01 , Anticipated
Name of Study	Seoul Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-07-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	IL-YANG Pharmaceuticals
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Ureter stone is a very common disease with a prevalence of 11.5%, 12.9% in men and 9.8% in women. Also, the recurrence rate of urinary tract stones within 10 years is high, about 38%. As a treatment method for ureter stone, surgical methods such as Extracorporeal shock wave lithotripsy, Ureterorenoscopy are widely used. If the size of stone is small and located at the bottom, observational therapy is also being performed. In addition, recent studies have shown that drug treatment with alpha-blockers is also effective. This study aims to analyze the difference in effectiveness compared to observational therapy when terazosin, one of the alpha blockers, is administered as 2mg QD or 5mg QD for lower urinary tract stones less than 10mm in diameter. Through this study, we will evaluate the effectiveness of alpha blockers for lower urinary tract stones and determine whether there is a significant difference depending on the dose.

Study Summary Information

Lay Summary

Ureter stone is a very common disease with a prevalence of 11.5&#37;, 12.9&#37; in men and 9.8&#37; in women. Also, the recurrence rate of urinary tract stones within 10 years is high, about 38&#37;.
As a treatment method for ureter stone, surgical methods such as Extracorporeal shock wave lithotripsy, Ureterorenoscopy are widely used. If the size of stone is small and located at the bottom, observational therapy is also being performed.
In addition, recent studies have shown that drug treatment with alpha-blockers is also effective. This study aims to analyze the difference in effectiveness compared to observational therapy when terazosin, one of the alpha blockers, is administered as 2mg QD or 5mg QD for lower urinary tract stones less than 10mm in diameter.
Through this study, we will evaluate the effectiveness of alpha blockers for lower urinary tract stones and determine whether there is a significant difference depending on the dose.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	1) Observational therapy group 2) terazosin 2mg QD for 4 weeks group 3) terazosin 5mg QD for 4 weeks group
Number of Arms	3
Arm 1	Arm Label Observational therapy group
	Target Number of Participant 68
	Arm Type No intervention
	Arm Description Do not take any medications, and drink plenty of water for up to 4 weeks while waiting for the stones to be released naturally.
Arm 2	Arm Label terazosin 2mg QD group
	Target Number of Participant 63
	Arm Type Experimental
	Arm Description Take terazosin 2mg by QD for 4 weeks until the stones naturally release.
Arm 3	Arm Label terazosin 5mg QD group
	Target Number of Participant 63
	Arm Type Experimental
	Arm Description Take terazosin 5mg by QD for 4 weeks until the stones naturally release.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N21.9)Calculus of lower urinary tract, unspecified Patients with lower urinary tract stones
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description 1) Men over 19 2) Those with lower urinary tract stones less than 10mm in diameter 3) A person who voluntarily decides to participate in this study and agrees in writing to the subject consent
Exclusion Criteria	1) People with urinary tract infection 2) A person with a severe hydronephrosis 3) Those who have multiple stones 4) Patients with ureteral stenosis 5) Patients who are currently taking Calcium Channel Blocker or Alpha Blocker 6) Those who are sensitive to alpha-blocker preparations 7) Patients with Systolic blood pressure <110mmHg 8) Patients who has a history of surgery related to the urinary tract 9) Others who are inappropriate to participate in research as judged by the Primary Investigator or other Investigators
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Natural excretion rate of lower urinary tract stones when waiting therapy or terazosin 2mg or 5mg was administered to patients with lower urinary tract stones for 4 weeks
Timepoint	Baseline, week 2, week 4
Secondary Outcome(s) 1
Outcome	The average number of days it takes for the lower urinary tract stones to be discharged when observational therapy or terazosin 2 mg or 5 mg is administered for up to 4 weeks to patients with lower urinary tract stones.
Timepoint	week 2, week 4

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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