Naftopidil 75mg for Improving Clearance of Urinary Stones

NCT ID: NCT02011737

Last Updated: 2013-12-13

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.

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

Keywords

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Medical Expulsive therapy

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

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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HAN, DEOK HYUN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deok Hyun Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Deok Hyun Han, MD

Role: CONTACT

Phone: 82-2-3410-6431

Email: [email protected]

Facility Contacts

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Deok Hyun Han, M.D.

Role: primary

Other Identifiers

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SMC2013-08-066

Identifier Type: -

Identifier Source: org_study_id