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Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Primary Purpose

Ureter Stones

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Naftopidil 75mg
Placebo for Naftopidil
Standard treatment
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureter Stones

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Donguk University Ilsan Hospital
  • Seoul National University Bundang Hospital
  • Kangwon National University Hospital
  • Seoul National University Hospital
  • National Medical Center
  • Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control groups with only analgesics

Naftopidil

Arm Description

Control groups will receive only analgesics.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Stone-free rate at 28th day of study
Duration to stone passage within 28days of study
amount of analgesics used for 28 days of study
Rate of active treatment
Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment

Full Information

First Posted
September 24, 2013
Last Updated
December 8, 2015
Sponsor
Seoul National University Hospital
Collaborators
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01952314
Brief Title
Medical Expulsive Therapy for Ureter Stone Using Naftopidil
Official Title
Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 patients with ureteral stones of sizes from 3 to 10 mm patients aged more than 18 years Randomization naftopidil 75 mg qd for 14 days or placebo Standard treatment with pain-killers were also applied.(aceclofenac) Follow-up for 28 days We confirm the stone free status by CT or X-ray films at 14th and 28th days. Rates of active treatment will be also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control groups with only analgesics
Arm Type
Placebo Comparator
Arm Description
Control groups will receive only analgesics.
Arm Title
Naftopidil
Arm Type
Active Comparator
Arm Description
This interventional group will receive analgesics and naftopidil 75mg po qd.
Intervention Type
Drug
Intervention Name(s)
Naftopidil 75mg
Other Intervention Name(s)
Flivas(TM) in South Korea
Intervention Description
naftopidil 75mg 1T qd hs
Intervention Type
Drug
Intervention Name(s)
Placebo for Naftopidil
Intervention Description
Placebo 1T qd hs
Intervention Type
Drug
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
Pain control
Intervention Description
Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
Primary Outcome Measure Information:
Title
Stone-free rate at 14th day of study
Description
Rate of stone-free as confirmed by non-contrast CT, intravenous urography or simple x-ray (only for radio-opaque stone)
Time Frame
14th day
Secondary Outcome Measure Information:
Title
Stone-free rate at 28th day of study
Time Frame
28th day
Title
Duration to stone passage within 28days of study
Time Frame
for 28 days
Title
amount of analgesics used for 28 days of study
Time Frame
for 28 days
Title
Rate of active treatment
Description
Active treatments include shock-wave lithotripsy, ureteroscopic ureterolithotomy, ureteral stenting or other surgical treatment
Time Frame
for 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Wook Jeong, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donguk University Ilsan Hospital
City
Goyang
State/Province
Kyunggi
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyunggi
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
National Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Medical Expulsive Therapy for Ureter Stone Using Naftopidil

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