Kidney StonesPhase 3NCT01560091
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
A Phase 3 study testing silodosin, Extra-corporeal shock wave lithotripsy and Tamsulosin in people with Kidney Stones, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- What is being tested?
- silodosin, Extra-corporeal shock wave lithotripsy and Tamsulosin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 to 70
- Non-diabetics
- White blood cell count and serum creatinine level within normal range
- Urine analysis consistent with absence of infection
- Negative urine culture
- Absence of subjective or objective fever
Show all 10Show fewer
- Ability to tolerate oral fluids and pain medication
- Unilateral ureteral calculus < 10mm visible on CT scan within the ureter
- Ability to make informed medical decisions regarding consent
- Willingness to follow up in the urology office
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Prior treatment for this particular stone
- Medical therapy only for stone disease
- Chronic narcotic use
- Current alpha blocker therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
Official title: Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL
Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. The investigators would like to see if there is some benefit to taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing stones to pass, but may allow them to pass more quickly because of the rapid onset of action.
The side effect profile for both drugs is quite similar and tolerable. Patients may experience some common side effects associated with tamsulosin, including abnormal ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged undesired erection).
Read more
Patients may experience some common side effects with both silodosin and tamsulosin including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious side effects are rare and include orthostatic hypotension, intra-operative floppy iris syndrome, syncope, and priapism.
Patients will experience the discomfort normally associated with kidney stones. All efforts will be made to alleviate these discomforts, including the use of the study medications. Patients will be able to take their routine prescribed pain medications, and will be asked to keep a record of their pain medication use.
The investigators will be randomly enrolling patients from all racial backgrounds and of both genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior treatment for the study.
The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. The secondary endpoints of this study include analgesic use, residual stones remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the need for hospitalization.
Read the detailed description
A comparison between two commonly used alpha blockers to determine if there is superiority in the secondary usage of aiding in stone passage
- Conditions
- Kidney Stones
- Being tested
- silodosin, Extra-corporeal shock wave lithotripsy, Tamsulosin
- Keywords
- clearance rate
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silodosinDrug
8mg PO Qday
Extra-corporeal shock wave lithotripsyProcedure or surgery
ESWL
TamsulosinDrug
Tamsulosin 0.4mg PO Qday
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Patients will receive ESWL and no medication Receives: Procedure: Extra-corporeal shock wave lithotripsy |
| Group B | Active comparator | Patients will receive Flomax after ESWL Receives: Procedure: Extra-corporeal shock wave lithotripsy; Drug: Tamsulosin |
| Group C | Active comparator | Patients will receive silodosin after ESWL Receives: Drug: silodosin; Procedure: Extra-corporeal shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of kidney stones (days)
The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. This outcome measure will be measured in days.
Measured: 1 year
Secondary outcomes (6)
Analgesic use
Analgesic use, number of pills of pain medication
Measured: 1 year
Residual stones remaining
Residual stones remaining, based on imaging
Measured: 1 year
need for re-treatment
need for re-treatment. Either the patient will need another ESWL, or hospitilization
Measured: 1 year
need for intervention
need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery
Measured: 1 year
steinstrasse clearance
steinstrasse clearance. Whether or not stone clearance is achieved or not
Measured: 1 year
need for hospitalization
need for hospitalization. either yes or no
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: accrual of subjects did not occur as anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Harkaway, Albert Einstein Healthcare Network
- Investigators
- Richard Harkaway, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560091
- Sponsor's protocol ID
- HN 4378
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2012
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL
- ClinicalTrials.gov ID
- NCT01560091
- Acronym / sponsor ID
- HN 4378
- Conditions
- Kidney Stones
- Keywords
- clearance rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: accrual of subjects did not occur as anticipated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Mar 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.
Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. The investigators would like to see if there is some benefit to taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing stones to pass, but may allow them to pass more quickly because of the rapid onset of action.
The side effect profile for both drugs is quite similar and tolerable. Patients may experience some common side effects associated with tamsulosin, including abnormal ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged undesired erection).
Patients may experience some common side effects with both silodosin and tamsulosin including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious side effects are rare and include orthostatic hypotension, intra-operative floppy iris syndrome, syncope, and priapism.
Patients will experience the discomfort normally associated with kidney stones. All efforts will be made to alleviate these discomforts, including the use of the study medications. Patients will be able to take their routine prescribed pain medications, and will be asked to keep a record of their pain medication use.
The investigators will be randomly enrolling patients from all racial backgrounds and of both genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior treatment for the study.
The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. The secondary endpoints of this study include analgesic use, residual stones remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the need for hospitalization.
Detailed description
A comparison between two commonly used alpha blockers to determine if there is superiority in the secondary usage of aiding in stone passage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Procedure: Extra-corporeal shock wave lithotripsyPatients will receive ESWL and no medication |
| Group B | Active comparator | Procedure: Extra-corporeal shock wave lithotripsy, Drug: TamsulosinPatients will receive Flomax after ESWL |
| Group C | Active comparator | Drug: silodosin, Procedure: Extra-corporeal shock wave lithotripsyPatients will receive silodosin after ESWL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults age 18 to 70
- Non-diabetics
- White blood cell count and serum creatinine level within normal range
- Urine analysis consistent with absence of infection
- Negative urine culture
Key exclusion criteria (8 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Prior treatment for this particular stone
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 |
|---|---|---|
| silodosin8mg PO Qday | Drug | Group C |
| Extra-corporeal shock wave lithotripsyESWL | Procedure or surgery | Group A, Group B, Group C |
| TamsulosinTamsulosin 0.4mg PO Qday | Drug | Group B |
Primary outcome
Clearance rate of kidney stones (days)
Time frame: 1 year
The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. This outcome measure will be measured in days.
6 secondary outcomes
Analgesic use
Time frame: 1 year
Residual stones remaining
Time frame: 1 year
need for re-treatment
Time frame: 1 year
need for intervention
Time frame: 1 year
steinstrasse clearance
Time frame: 1 year
need for hospitalization
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Richard Harkaway, MD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing silodosin, Extra-corporeal shock wave lithotripsy and Tamsulosin in people with Kidney Stones, run by Albert Einstein Healthcare Network at 1 site in United States.
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 10 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clearance rate of kidney stones (days) (time frame: 1 year). 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 17 Feb 2017.