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Medical Expulsive Therapy for Ureter Stone Using Naftopidil

NCT ID: NCT01952314

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Detailed Description

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1. Enrollment

1. patients with ureteral stones of sizes from 3 to 10 mm
2. patients aged more than 18 years
2. Randomization

1. naftopidil 75 mg qd for 14 days or placebo
2. Standard treatment with pain-killers were also applied.(aceclofenac)
3. Follow-up for 28 days

1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.
2. Rates of active treatment will be also evaluated.

Conditions

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Ureter Stones

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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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 or tramadol37.5mg/acetaminophen 325mg on demand

Naftopidil

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

Group Type ACTIVE_COMPARATOR

Naftopidil 75mg

Intervention Type DRUG

naftopidil 75mg 1T qd hs

Standard treatment

Intervention Type DRUG

Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand

Interventions

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Naftopidil 75mg

naftopidil 75mg 1T qd hs

Intervention Type DRUG

Placebo for Naftopidil

Placebo 1T qd hs

Intervention Type DRUG

Standard treatment

Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand

Intervention Type DRUG

Other Intervention Names

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Flivas(TM) in South Korea Pain control

Eligibility Criteria

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Inclusion Criteria

* \>= 20 years
* single 3 to 10 mm ureter stone (longest diameter)

Exclusion Criteria

* Presence of multiple ureter stones
* Renal insufficiency (serum Cr \> 1.4 mg/dL)
* Febrile urinary tract infections(fever \> 38°C, evidence of urinary infection)
* pregnancy or breast feeding
* solitary kidney
* hypersensitivity to naftopidil
* current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
* moderate or severe cardiovascular or cerebrovascular disease
* hepatic dysfunction (\>2 x normal upper limit)
* significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Genetic disorder such as 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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Donguk University Ilsan Hospital

Goyang, Kyunggi, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, Kyunggi, South Korea

Site Status

Kangwon National University Hospital

Chuncheon, , 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 Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH-URO-2012-03-MET

Identifier Type: OTHER

Identifier Source: secondary_id

SNUBH-URO-2012-03

Identifier Type: -

Identifier Source: org_study_id