Naftopidil 75mg for Improving Clearance of Urinary Stones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Calculi Ureter Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naftopidil

Naftopidil 75mg once daily

Group Type ACTIVE_COMPARATOR

naftopidil 75mg

Intervention Type DRUG

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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naftopidil 75mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No