Medical Expulsive Therapy for Ureter Stone Using Naftopidil | NCT01952314

Studies
Medical Expulsive Therapy for Ureter Stone Using Naftopidil

NCT01952314

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 10, 2015Estimated

Enrollment

150Actual

Phase

Phase 3

Conditions

Ureter Stones

Interventions

Naftopidil 75mg
Placebo for Naftopidil
Standard treatment

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SNUBH-URO-2012-03-MET	Other Identifier	SNU Bundang Hospital IRB

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 24, 2013

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Name	Class
Dong-A ST Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Enrollment
1. patients with ureteral stones of sizes from 3 to 10 mm
2. patients aged more than 18 years
Randomization
1. naftopidil 75 mg qd for 14 days or placebo
2. Standard treatment with pain-killers were also applied.(aceclofenac)
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control groups with only analgesics	Placebo Comparator	Control groups will receive only analgesics.	Drug: Placebo for Naftopidil Drug: Standard treatment
Naftopidil	Active Comparator	This interventional group will receive analgesics and naftopidil 75mg po qd.	Drug: Naftopidil 75mg Drug: Standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naftopidil 75mg	Drug	naftopidil 75mg 1T qd hs	Naftopidil	Flivas(TM) in South Korea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone-free rate at 14th day of study	Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone)	14th day

Secondary Outcomes

Measure	Description	Time Frame
Stone-free rate at 28th day of study		28th day
Duration to stone passage within 28days of study		for 28 days
amount of analgesics used for 28 days of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Wook Jeong, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Donguk University Ilsan Hospital		Goyang	Kyunggi		South Korea
Seoul National University Bundang Hospital

Intervention Browse Module

MeSH Terms

ID	Term
C064357	naftopidil
D000698	Analgesia

Ancestor Terms

ID	Term
D000760	Anesthesia and Analgesia

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