Kidney StonePhase 3SiloMETNCT02090439
Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
A Phase 3 study testing Silodosin in people with Kidney Stone and Expulsive Medical Therapy, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Stone, Expulsive Medical Therapy
- What is being tested?
- Silodosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2014to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men
- Women on oral contraception (for women of childbearing age).
- 18 to 60 years.
- First admission to the episode of renal colic without evidence of complication (afebrile without renal input, negative beta-hCG (women of childbearing age) without severe vomiting without uropathy malformation known underlying balance sheet. ).
- In ability to deliver its consent.
- patient with a single calculation pelvic ureteral 4 to 10 mm cross-sectional diameter, with or without calyx calculations (not obstructive), but other calculation ureter.
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- Unique pelvic stone :
- Proven by imaging: helical scan without contrast injection-ASP abdominopelvic.
- Radio-opaque to the ASP.
- More than 3mm and <11mm (4 to 10 mm) of cross-sectional diameter.
Who cannot join
- Pregnant or lactating women scalable
- No oral contraception
- Contraception by intrauterine device .
- Concurrent infection ( positive urine test strip for Nitrites and / or general signs tanks (T ° C > 38 ° 5 or <36 ° 5 or chills) .
- Renal failure ( Creatinine clearance calculated by Cockcroft and Gault <60 mL / min).
- Single functional kidney .
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- Treatment with calcium channel blockers or alpha blockers.
- Recent or upcoming cataract surgery .
- Orthostatic hypotension .
- A history of peptic ulcer disease , liver disease , allergy to paracetamol , the ketoprofen .
- History of stroke , heart disease, diabetes.
- History of allergy to any treatment plans.
- Refusal to enter the protocol.
- Already included in the protocol.
- Medication against -indicated in combination with NSAI (vitamin K ..)
- Hepatic Impairment
- Participation in other biomedical research
- Patients with a history of hypersensitivity such as bronchospasm , asthma, rhinitis , urticaria
- Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis
- History of gastrointestinal bleeding or perforation during previous treatment with NSAI or history of gastrointestinal diseases such as ulcerative colitis, Crohn's diseases, gastrointestinal bleeding , cerebrovascular bleeding or other bleeding evolving
- Patients receiving treatment associated may increase the risk of ulceration or bleeding (glucocorticoids , selective serotonin reuptake inhibitors and antiplatelet agents such as aspirin )
- Patients with uncontrolled hypertension, congestive heart failure , ischemic heart disease, peripheral arterial disease, and / or a history of stroke (including transient ischemic attack)
- Patients treated with potassium-sparing drugs
- Pelvic stone :
- Multiple
- Size < 4 mm or > 10mm
- Radiolucent
- Not formally identified by imaging.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH Loire Vendée Océan
Challans, 85302
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925
About this study
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . "The abdominopelvic CT scan without injection of contrast is the examination of choice.
Current recommendations in the management of gallstone colic simply based on the joint use of analgesics , anti inflammatory drugs and control of water intake .
Read more
The mechanism of analgesic action of this treatment is a decrease in the pressure in the cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of urine . )
The expulsive medical therapy remains under evaluation. The French Association of Urology does not recommend at this time for lack of evidence deemed sufficient.
For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended (grade 1A) . However, there are less formal studies of their effectiveness .
Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for pelvic stones 4 to 10mm .
- Conditions
- Kidney Stone, Expulsive Medical Therapy
- Being tested
- Silodosin
- 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
| Study group | Role | What they receive |
|---|---|---|
| standard treatment with Silodosin | Experimental | Silodosin Receives: Drug: Silodosin |
| standard treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to expel kidney stone
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Following difficulties in patient recruitment, we were forced to stop the study prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François LUYCKX, PH, Principal investigator, CHD Vendée La Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090439
- Sponsor's protocol ID
- CHD 062-13
- Acronym
- SiloMET
- Status last verified
- Nov 2015
- First submitted
- 14 Mar 2014
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.
- ClinicalTrials.gov ID
- NCT02090439
- Acronym / sponsor ID
- SiloMET / CHD 062-13
- Conditions
- Kidney Stone, Expulsive Medical Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following difficulties in patient recruitment, we were forced to stop the study prematurely.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Mar 2014 (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.
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . "The abdominopelvic CT scan without injection of contrast is the examination of choice.
Current recommendations in the management of gallstone colic simply based on the joint use of analgesics , anti inflammatory drugs and control of water intake .
The mechanism of analgesic action of this treatment is a decrease in the pressure in the cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of urine . )
The expulsive medical therapy remains under evaluation. The French Association of Urology does not recommend at this time for lack of evidence deemed sufficient.
For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended (grade 1A) . However, there are less formal studies of their effectiveness .
Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for pelvic stones 4 to 10mm .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment with Silodosin | Experimental | Drug: SilodosinSilodosin |
| standard treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Men
- Women on oral contraception (for women of childbearing age).
- 18 to 60 years.
- First admission to the episode of renal colic without evidence of complication (afebrile without renal input, negative beta-hCG (women of childbearing age) without severe vomiting without uropathy malformation known underlying balance sheet. ).
- In ability to deliver its consent.
Key exclusion criteria (28 listed)
- Pregnant or lactating women scalable
- No oral contraception
- Contraception by intrauterine device .
- Concurrent infection ( positive urine test strip for Nitrites and / or general signs tanks (T ° C > 38 ° 5 or <36 ° 5 or chills) .
- Renal failure ( Creatinine clearance calculated by Cockcroft and Gault <60 mL / min).
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 |
|---|---|---|
| Silodosin | Drug | standard treatment with Silodosin |
Primary outcome
time to expel kidney stone
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Following difficulties in patient recruitment, we were forced to stop the study prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
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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.
François LUYCKX, PH principal investigator
CHD Vendée La Roche sur Yon
2 sites 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 in people with Kidney Stone and Expulsive Medical Therapy, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
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 28 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: stopped early, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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 stopped early (reason given: Following difficulties in patient recruitment, we were forced to stop the study prematurely.). Results are not available in the source record.
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?
time to expel kidney stone (time frame: 28 days). 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 11 Feb 2016.