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Naftopidil 75mg for Improving Clearance of Urinary Stones

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Unknown
Phase 4

Conditions

Ureter Calculi
Kidney Calculi

Treatments

Drug: naftopidil 75mg

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02011737
SMC2013-08-066

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 2 patient groups, including a placebo group

Naftopidil
Active Comparator group
Description:
Naftopidil 75mg once daily
Treatment:
Drug: naftopidil 75mg
Placebo
Placebo Comparator group
Description:
Placebo once daily

Trial contacts and locations

1

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Central trial contact

Deok Hyun Han, MD

Data sourced from clinicaltrials.gov

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