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The Effect of Naftopidil for the Double-J Stent Discomfort

NCT ID: NCT01959074

Last Updated: 2015-12-10

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

Brief Summary

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This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.

Detailed Description

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1. Enrollment

1. patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
2. patients aged more than 20 years
2. Randomization

1. naftopidil 75 mg qd or placebo until Double-J stent removal
2. Standard treatment with pain-killers on demand were also applied.(aceclofenac)
3. Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)

Conditions

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Disorder of Urinary Stent

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

This interventional group will receive analgesics and naftopidil 75mg po qd.

Group Type ACTIVE_COMPARATOR

Naftopidil

Intervention Type DRUG

Naftopidil 75mg 1T qd hs

Standard treatment

Intervention Type DRUG

aceclofenac 100mg on demand

Control groups with only analgesics

Control groups will receive only analgesics

Group Type PLACEBO_COMPARATOR

Placebo for Naftopidil

Intervention Type DRUG

Placebo 1T qd hs

Standard treatment

Intervention Type DRUG

aceclofenac 100mg on demand

Interventions

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Naftopidil

Naftopidil 75mg 1T qd hs

Intervention Type DRUG

Placebo for Naftopidil

Placebo 1T qd hs

Intervention Type DRUG

Standard treatment

aceclofenac 100mg on demand

Intervention Type DRUG

Other Intervention Names

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Flivas(TM) in South Korea Aceclofenac

Eligibility Criteria

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Inclusion Criteria

* \>= 20 years
* undergoing unilateral retrograde double J (DJ) stent placement planned for 5-15 days indwelling

Exclusion Criteria

* after percutaneous nephrolithotomy, open or laparoscopic ureterolithotomy presence of ureteral stone
* renal insufficiency (serum Cr \> 1.4)
* febrile urinary tract infection (fever \> 38.0°C, evidence of urinary infection )
* pregnancy or breast feeding
* solitary kidney
* hypersensitivity to Naftopidil
* current use of any alpha blocker, calcium channel blocker, corticosteroid moderate or sever cardiovascular or cerebrovascular disease
* hepatic dysfunction
* prior history of pelvic surgery or irradiation
* prior history of transurethral resection of bladder tumor or prostate surgery
* significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* genetic disorder such ad galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Wook Jeong

M.D, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Wook Jeong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Kyunggi, South Korea

Site Status

Kangwon National University Hospital

Chuncheon, , South Korea

Site Status

Donguk University Ilsan Hospital

Goyang, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

National Medical Center

Seoul, , South Korea

Site Status

Seoul National University Boramae Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-URO-2012-04-DJ

Identifier Type: OTHER

Identifier Source: secondary_id

SNUH-URO-2012-04

Identifier Type: -

Identifier Source: org_study_id