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Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones

NCT01533389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2013-11-20

No results posted yet for this study

Summary

A lower ureteral calculus, which measures 5 millimeters and less, may be easily expelled by symptomatic therapy. Actually, it has about a 50% chance of successful expulsion.

However, a complication such as urinary tract infection or hydronephrosis or persistent pain may occur before it is expelled. Thus, it is imperative to minimize the occurrence of complications in the process of expectant treatment and also to reduce the time required to expel calculi.

Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily.

This clinical trial is to evaluate the efficacy of silodosin, a selective α1A-blocker, on calculous expulsion in expectant treatment for patients with lower and mid ureteral calculi.

Conditions

  • Ureteral Stone

Interventions

DRUG

Silodosin

Drug: silodosin dosage form : capsule dosage : placebo 4mg\*2 (8mg) frequency and duration : QD, 4weeks Arms: Placebo

DRUG

Placebo

dosage form : capsule dosage : placebo 4mg\*2 (8mg) frequency and duration : QD, 4weeks

Sponsors & Collaborators

Principal Investigators

  • Gwan-Joong Joo, Ph.D · Kangbuk Samsung Hospital

  • Tae-Yoong Jeong, Ph.D · Myongji Hospital

  • Young-Sik Kim, Ph.D · National Health Insurance Service Ilsan Hospital

  • Tak-Geun Yoo, Ph.D · Eulji Central Hospital

  • Jae-Yong Jeong, Ph.D · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533389 on ClinicalTrials.gov