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

NCT01533389 | Completed Phase 4

• 1 other identifier: CWP-SDS-404
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Expulsion rate of stones

  1 week, 2 weeks, 4 weeks to visit and inspected. (Last visit four weeks) Results when the exhaust is used.

  4 weeks

Secondary Outcomes (4)

• Stone expulsion time

  every 1 week or 2 weeks

• Migration distance of stone

  every 1 week or 2 weeks

• Frequency of administration of oral or injectable analgesics

  every 1 week or 2 weeks

• Number of cases where subjects visited ER due to uncontrolled pains

  every 1 week or 2 weeks

Study Arms (2)

Silodosin

EXPERIMENTAL

8mg QD

Drug: Silodosin

Placebo

PLACEBO COMPARATOR

8mg QD

Drug: Placebo

Interventions

Silodosin DRUG

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

Silodosin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or female patients aged 20 and over
• Patients having ureteral calculi located mid or lower ureter on abdominal radiograms or excretory urograms or non-enhanced computed tomograms.
• Patients whose calculi measure 10 millimeters and less.
• Patients who voluntarily decided to take part in this clinical trial and gave written consent.

You may not qualify if:

• Patients who do not want to undergo expectant treatment
• Female patients who are pregnant or nursing
• Patients with febrile urinary tract infection or severe hydronephrosis or ulcerative diseases or hypotension.
• Patients with severe hepatic dysfunction(e.g. hepatic failure, hepatic cirrhosis, icterus, hepatoma)
• Patients who take α-blocker or α/β-blockers or calcium-channel blockers or steroid drugs
• Patients with multiple ureteral calculi
• Patients whose urinary tracts are anatomically deformed or stenosed
• Patients who underwent invasive operations on their ureters before
• Patients whose blood creatinine levels are 2mg/dL and over
• Patients who are hypersensitive to silodosin
• Patients who take part in clinical trials other than this one
• Patients judged to be inappropriate for this clinical trial by investigators

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (5)

NHIC Ilsan Hospital

Goyang-si, Gyonggi-Do, 410-719, South Korea

Location

Myongji Hospital

Goyang-si, Gyonggi-Do, 412-270, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, Seoul, 110-746, South Korea

Location

Inje Univ. Sanggye Paik Hospital

Seoul, Seoul, 139-707, South Korea

Location

Eulji General Hospital

Seoul, Seoul, 139-711, South Korea

Location

MeSH Terms

Conditions

Ureterolithiasis

Interventions

silodosin

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Gwan-Joong Joo, Ph.D

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Tae-Yoong Jeong, Ph.D

  Myongji Hospital

  PRINCIPAL INVESTIGATOR

• Young-Sik Kim, Ph.D

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Tak-Geun Yoo, Ph.D

  Eulji Central Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Yong Jeong, Ph.D

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 15, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

KR (5)