Naftopidil 75mg for Improving Clearance of Urinary Stones

Phase 4

• Conditions: Kidney Calculi; Ureter Calculi
• Interventions: Drug: naftopidil 75mg

• Registration Number: NCT02011737
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13
• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Radio-opaque (identifiable in KUB) ureter or kidney calculi
• size criteria is from 5mm to 15mm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftopidil	naftopidil 75mg	Naftopidil 75mg once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference of the treatment success rate after ESWL between treatment group and placebo group	4, 6 weeks after ESWL	Treatment success is defined as no or less than 3 mm size remnant stone
Adverse Event	2,4,6weeks	Rate of total Adverse Events and Adverse Events relevant to Investigational drug
pain scale	baseline, 2, 4, 6 weeks	visual analogue pain scale due to urinary stone
rate of additional intervention	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of