Naftopidil 75mg for Improving Clearance of Urinary Stones

December 10, 2013 updated by: HAN, DEOK HYUN, Samsung Medical Center

The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Deok Hyun Han, M.D.
        • Sub-Investigator:
          • Seol Ho Choo, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Naftopidil
Naftopidil 75mg once daily
Drug: naftopidil 75mg
PLACEBO_COMPARATOR: Placebo
Placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
Time Frame: 2 weeks after ESWL
Treatment success is defined as no or less than 3 mm size remnant stone
2 weeks after ESWL

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the treatment success rate after ESWL between treatment group and placebo group
Time Frame: 4, 6 weeks after ESWL
Treatment success is defined as no or less than 3 mm size remnant stone
4, 6 weeks after ESWL
Adverse Event
Time Frame: 2,4,6weeks
Rate of total Adverse Events and Adverse Events relevant to Investigational drug
2,4,6weeks
pain scale
Time Frame: baseline, 2, 4, 6 weeks
visual analogue pain scale due to urinary stone
baseline, 2, 4, 6 weeks
rate of additional intervention
Time Frame: 6 week
incidence of additional intervention for the urinary stone ex> ureteral stent insertion, percutaneous nephrostomy, ureteroscopic ureterolithotomy, percutaneous nephrolithotomy, laparoscopic stone removal and so on
6 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to stone expulsion
Time Frame: 2,4,6week
the time (days) elapsed from first ESWL to the expulsion of the stone
2,4,6week
Number of ESWL
Time Frame: 6week
The number of required ESWL for the stone expulsion
6week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC2013-08-066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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