Naftopidil 75mg for Improving Clearance of Urinary Stones

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Samsung Medical Center
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
HAN, DEOK HYUN, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02011737
First received: December 10, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Treatment success is defined as no or less than 3 mm size remnant stone

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

  • pain scale [ Time Frame: baseline, 2, 4, 6 weeks ] [ Designated as safety issue: No ]
    visual analogue pain scale due to urinary stone

  • rate of additional intervention [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    the time (days) elapsed from first ESWL to the expulsion of the stone

  • Number of ESWL [ Time Frame: 6week ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HAN, DEOK HYUN, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02011737     History of Changes
Other Study ID Numbers: SMC2013-08-066
Study First Received: December 10, 2013
Last Updated: December 10, 2013
Health Authority: Korea: Ministry of Food and Drug Safety
South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Medical Expulsive therapy

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

ClinicalTrials.gov processed this record on September 18, 2014