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
  Purpose

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.


Condition Intervention Phase
Ureteral Stone
Drug: Silodosin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 114
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
8mg QD
Drug: Silodosin

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

Arms: Placebo

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533389

Locations
Korea, Republic of
Myongji Hospital
Goyang-Si, Gyonggi-Do, Korea, Republic of, 412-270
NHIC Ilsan Hospital
Goyang-Si, Gyonggi-Do, Korea, Republic of, 410-719
Eulji General Hospital
Seoul, Korea, Republic of, 139-711
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of, 110-746
Inje Univ. Sanggye Paik Hospital
Seoul, Korea, Republic of, 139-707
Sponsors and Collaborators
JW Pharmaceutical
Investigators
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
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01533389     History of Changes
Other Study ID Numbers: CWP-SDS-404
Study First Received: February 6, 2012
Last Updated: November 18, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014