Medical Expulsive Therapy for Ureter Stone Using Naftopidil

Ureter Stones Clinical Trial

Official title: Medical Expulsive Therapy for Ureter Stone Using Naftopidil: Multicenter, Randomized, Double-blind, Placebo Controlled Study

Status Completed

Clinical Trial Summary

This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Clinical Trial Description

1. Enrollment

1. patients with ureteral stones of sizes from 3 to 10 mm

2. patients aged more than 18 years

2. Randomization

1. naftopidil 75 mg qd for 14 days or placebo

2. Standard treatment with pain-killers were also applied.(aceclofenac)

3. Follow-up for 28 days

1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.

2. Rates of active treatment will be also evaluated. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureter Stones
• Ureteral Calculi
• Ureterolithiasis

• NCT number: NCT01952314
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Completion date: August 2015