Naftopidil 75mg for Improving Clearance of Urinary Stones
The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 13, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedDecember 13, 2013
December 1, 2013
1 year
December 10, 2013
December 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 weeks after ESWL
Secondary Outcomes (4)
Difference of the treatment success rate after ESWL between treatment group and placebo group
4, 6 weeks after ESWL
Adverse Event
2,4,6weeks
pain scale
baseline, 2, 4, 6 weeks
rate of additional intervention
6 week
Other Outcomes (2)
time to stone expulsion
2,4,6week
Number of ESWL
6week
Study Arms (2)
Naftopidil
ACTIVE COMPARATORNaftopidil 75mg once daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- Radio-opaque (identifiable in KUB) ureter or kidney calculi
- size criteria is from 5mm to 15mm
You may not qualify if:
- Symptomatic acute urinary tract infection during the run-in period
- severe hydronephrosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Dong-A ST Co., Ltd.collaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deok Hyun Han, M.D.
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 13, 2013
Study Start
February 1, 2014
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
December 13, 2013
Record last verified: 2013-12