Naftopidil 75mg for Improving Clearance of Urinary Stones

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

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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