Ureteral StonePhase 4STONENCT01533389
Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones
A Phase 4 study testing Silodosin in people with Ureteral Stone, run by JW Pharmaceutical at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ureteral Stone
- What is being tested?
- Silodosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
NHIC Ilsan Hospital
Goyang-si, Gyonggi-Do, 410-719
Myongji Hospital
Goyang-si, Gyonggi-Do, 412-270
Kangbuk Samsung Medical Center
Seoul, Seoul, 110-746
Inje Univ. Sanggye Paik Hospital
Seoul, Seoul, 139-707
Eulji General Hospital
Seoul, Seoul, 139-711
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Ureteral Stone
- Being tested
- Silodosin, Placebo
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Drug: silodosin dosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks
Arms: Placebo
PlaceboDrug
dosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | 8mg QD Receives: Drug: Silodosin |
| Placebo | Placebo comparator | 8mg QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion rate of stones
1 week, 2 weeks, 4 weeks to visit and inspected. (Last visit four weeks) Results when the exhaust is used.
Measured: 4 weeks
Secondary outcomes (4)
Stone expulsion time
Measured: every 1 week or 2 weeks
Migration distance of stone
Measured: every 1 week or 2 weeks
Frequency of administration of oral or injectable analgesics
Measured: every 1 week or 2 weeks
Number of cases where subjects visited ER due to uncontrolled pains
Measured: every 1 week or 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gwan-Joong Joo, Ph.D, Principal investigator, Kangbuk Samsung HospitalTae-Yoong Jeong, Ph.D, Principal investigator, Myongji HospitalYoung-Sik Kim, Ph.D, Principal investigator, National Health Insurance Service Ilsan HospitalTak-Geun Yoo, Ph.D, Principal investigator, Eulji Central HospitalJae-Yong Jeong, Ph.D, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533389
- Sponsor's protocol ID
- CWP-SDS-404
- Acronym
- STONE
- Status last verified
- Nov 2013
- First submitted
- 6 Feb 2012
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01533389
- Acronym / sponsor ID
- STONE / CWP-SDS-404
- Conditions
- Ureteral Stone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: Silodosin8mg QD |
| Placebo | Placebo comparator | Drug: Placebo8mg QD |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilodosinDrug: silodosin dosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks Arms: Placebo | Drug | Silodosin |
| Placebodosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks | Drug | Placebo |
Primary outcome
Expulsion rate of stones
Time frame: 4 weeks
1 week, 2 weeks, 4 weeks to visit and inspected. (Last visit four weeks) Results when the exhaust is used.
4 secondary outcomes
Stone expulsion time
Time frame: every 1 week or 2 weeks
Migration distance of stone
Time frame: every 1 week or 2 weeks
Frequency of administration of oral or injectable analgesics
Time frame: every 1 week or 2 weeks
Number of cases where subjects visited ER due to uncontrolled pains
Time frame: every 1 week or 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
Related trials for Ureteral Stone
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwan-Joong Joo, Ph.D principal investigator
Kangbuk Samsung Hospital
Tae-Yoong Jeong, Ph.D principal investigator
Myongji Hospital
Young-Sik Kim, Ph.D principal investigator
National Health Insurance Service Ilsan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin in people with Ureteral Stone, run by JW Pharmaceutical at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion rate of stones (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.