search
Back to results

Naftopidil 75mg for Improving Clearance of Urinary Stones

Primary Purpose

Kidney Calculi, Ureter Calculi

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
naftopidil 75mg
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Medical Expulsive therapy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Radio-opaque (identifiable in KUB) ureter or kidney calculi
  • size criteria is from 5mm to 15mm

Exclusion Criteria:

  • Symptomatic acute urinary tract infection during the run-in period
  • severe hydronephrosis
  • 2 or more urinary stones
  • Radiolucent (non-visible in KUB) stone
  • recent intervention for the urinary stone within 6 month
  • Patients who have ureteral stent
  • over 2.0 mg/dl of serum creatinine level
  • severe hepatic dysfunction
  • orthostatic hypotension
  • current usage of alpha-adrenergic blocker or calcium channel blocker
  • Pregnant or nursing women
  • Age under 15 year
  • severe or uncontrolled medical conditions

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naftopidil

Placebo

Arm Description

Naftopidil 75mg once daily

Placebo once daily

Outcomes

Primary Outcome Measures

Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
Treatment success is defined as no or less than 3 mm size remnant stone

Secondary Outcome Measures

Difference of the treatment success rate after ESWL between treatment group and placebo group
Treatment success is defined as no or less than 3 mm size remnant stone
Adverse Event
Rate of total Adverse Events and Adverse Events relevant to Investigational drug
pain scale
visual analogue pain scale due to urinary stone
rate of additional intervention
incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on

Full Information

First Posted
December 10, 2013
Last Updated
December 10, 2013
Sponsor
Samsung Medical Center
Collaborators
Dong-A ST Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02011737
Brief Title
Naftopidil 75mg for Improving Clearance of Urinary Stones
Official Title
The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.
Detailed Description
Prospective, Single-center, Double blind, Randomized controlled trial Treatment - Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones. Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Ureter Calculi
Keywords
Medical Expulsive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naftopidil
Arm Type
Active Comparator
Arm Description
Naftopidil 75mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
naftopidil 75mg
Primary Outcome Measure Information:
Title
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
Description
Treatment success is defined as no or less than 3 mm size remnant stone
Time Frame
2 weeks after ESWL
Secondary Outcome Measure Information:
Title
Difference of the treatment success rate after ESWL between treatment group and placebo group
Description
Treatment success is defined as no or less than 3 mm size remnant stone
Time Frame
4, 6 weeks after ESWL
Title
Adverse Event
Description
Rate of total Adverse Events and Adverse Events relevant to Investigational drug
Time Frame
2,4,6weeks
Title
pain scale
Description
visual analogue pain scale due to urinary stone
Time Frame
baseline, 2, 4, 6 weeks
Title
rate of additional intervention
Description
incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on
Time Frame
6 week
Other Pre-specified Outcome Measures:
Title
time to stone expulsion
Description
the time (days) elapsed from first ESWL to the expulsion of the stone
Time Frame
2,4,6week
Title
Number of ESWL
Description
The number of required ESWL for the stone expulsion
Time Frame
6week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radio-opaque (identifiable in KUB) ureter or kidney calculi size criteria is from 5mm to 15mm Exclusion Criteria: Symptomatic acute urinary tract infection during the run-in period severe hydronephrosis 2 or more urinary stones Radiolucent (non-visible in KUB) stone recent intervention for the urinary stone within 6 month Patients who have ureteral stent over 2.0 mg/dl of serum creatinine level severe hepatic dysfunction orthostatic hypotension current usage of alpha-adrenergic blocker or calcium channel blocker Pregnant or nursing women Age under 15 year severe or uncontrolled medical conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deok Hyun Han, MD
Phone
82-2-3410-6431
Email
deokhyun.han@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deok Hyun Han, M.D.
Organizational Affiliation
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deok Hyun Han, M.D.
Phone
+82-10-9933-5125
Email
deokhyun.han@gmail.com
First Name & Middle Initial & Last Name & Degree
Deok Hyun Han, M.D.
First Name & Middle Initial & Last Name & Degree
Seol Ho Choo, M.D.

12. IPD Sharing Statement

Learn more about this trial

Naftopidil 75mg for Improving Clearance of Urinary Stones

We'll reach out to this number within 24 hrs