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Naftopidil 75mg for Improving Clearance of Urinary Stones

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by HAN, DEOK HYUN, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011737
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
HAN, DEOK HYUN, Samsung Medical Center
  Purpose
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.

Condition Intervention Phase
Kidney Calculi Ureter Calculi Drug: naftopidil 75mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by HAN, DEOK HYUN, Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • Adverse Event [ Time Frame: 2,4,6weeks ]
    Rate of total Adverse Events and Adverse Events relevant to Investigational drug

  • pain scale [ Time Frame: baseline, 2, 4, 6 weeks ]
    visual analogue pain scale due to urinary stone

  • 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


Other Outcome Measures:
  • time to stone expulsion [ Time Frame: 2,4,6week ]
    the time (days) elapsed from first ESWL to the expulsion of the stone

  • Number of ESWL [ Time Frame: 6week ]
    The number of required ESWL for the stone expulsion


Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naftopidil
Naftopidil 75mg once daily
Drug: naftopidil 75mg
Placebo Comparator: Placebo
Placebo once daily

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011737


Contacts
Contact: Deok Hyun Han, MD 82-2-3410-6431 deokhyun.han@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Deok Hyun Han, M.D.    +82-10-9933-5125    deokhyun.han@gmail.com   
Principal Investigator: Deok Hyun Han, M.D.         
Sub-Investigator: Seol Ho Choo, M.D.         
Sponsors and Collaborators
Samsung Medical Center
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Deok Hyun Han, M.D. Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

Responsible Party: HAN, DEOK HYUN, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02011737     History of Changes
Other Study ID Numbers: SMC2013-08-066
First Submitted: December 10, 2013
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by HAN, DEOK HYUN, Samsung Medical Center:
Medical Expulsive therapy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Naftopidil
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Platelet Aggregation Inhibitors