NCT01952314

Medical Expulsive Therapy for Ureter Stone Using Naftopidil

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ureter Stones

Interventions

Type	Name	Description
DRUG	Naftopidil 75mg	naftopidil 75mg 1T qd hs
DRUG	Placebo for Naftopidil	Placebo 1T qd hs
DRUG	Standard treatment	Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-09-27
• Last updated: 2015-12-10

Locations

6 sites across 1 country: South Korea