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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01533389
First received: February 6, 2012
Last updated: November 18, 2013
Last verified: November 2013

February 6, 2012
November 18, 2013
October 2011
March 2012   (final data collection date for primary outcome measure)
Expulsion rate of stones [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
1 week, 2 weeks, 4 weeks to visit and inspected. (Last visit four weeks) Results when the exhaust is used.
Same as current
Complete list of historical versions of study NCT01533389 on ClinicalTrials.gov Archive Site
  • Stone expulsion time [ Time Frame: every 1 week or 2 weeks ] [ Designated as safety issue: Yes ]
  • Migration distance of stone [ Time Frame: every 1 week or 2 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of administration of oral or injectable analgesics [ Time Frame: every 1 week or 2 weeks ] [ Designated as safety issue: Yes ]
  • Number of cases where subjects visited ER due to uncontrolled pains [ Time Frame: every 1 week or 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones
A 4-week, Double-blind, Randomized, Comparative and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones.

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.

Lower and mid ureteral calculi, accounting for approximately 70% of ureteral calculi, has a high chance of successful treatment thanks to ureteroscopic lithotripsy or extracorporeal shock wave lithotripsy (ESWL)1-3), but at the same time have problems of postprocedural complications and high expenses4). 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 expulsion5). 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.

It has been recently reported that pharmacotherapy is adhibited to the expulsion of urinary calculi and the relief of pain. The migration of ureteral calculi is influenced by both the calculus and the ureter. In the case of the calculus, size, shape, number and location influence it. In regard to the ureter, it is significantly influenced by the cramp of the ureteral smooth muscle, the edema of the ureteral submucosa, the pain caused by the calculus and the activities of adrenoreceptors6).

Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily. Ureteral obstruction, caused by urinary calculi, obtunds ureteral peristalsis but strengthens ureteral contraction, which may cause urinary retention or regurgitation7-8). In this connection, studies have been conducted as to methods to reduce abnormal urinary reaction caused by urinary calculi and to smoothen uroflow. Currently, hormone drugs including hydroxyprogesterone, prostaglandin synthetase inhibitors, calcium-channel antagonists, α1-blockers and steroid drugs are used to expel urinary calculi and to suppress pain. The guidelines on urinary calculi, drawn up in 2007, recommend using α-blockers as they are superior to other drugs in efficacy9-12).

The drug to be used in this clinical trial, silodosin, was registered under the proprietary name of 'THRUPAS® Capsule 4mg' and is being marketed after being authorized by Korea Food and Drug Administration (FDA), which selectively acts on the α1A-adrenoreceptor.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ureteral Stone
  • 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
  • Experimental: Silodosin
    8mg QD
    Intervention: Drug: Silodosin
  • Placebo Comparator: Placebo
    8mg QD
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
August 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01533389
CWP-SDS-404
No
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Gwan-Joong Joo, Ph.D Kangbuk Samsung Medical center
Principal Investigator: Tae-Yoong Jeong, Ph.D Myongji Hospital
Principal Investigator: Young-Sik Kim, Ph.D NHIC Ilsan hospital
Principal Investigator: Tak-Geun Yoo, Ph.D Eulji Central Hospital
Principal Investigator: Jae-Yong Jeong, Ph.D Inje University
JW Pharmaceutical
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP