Kidney StonesNCT00583258
A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones
A study testing Alfuzosin (Xatral) in people with Kidney Stones, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Alfuzosin (Xatral)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Oct 2009
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
- stone radiopaque on KUB, distal to the sacro-iliac joint
- patient suitable for discharge from ER
- patient willing to return for follow-up on a weekly basis for maximum 4 visits
Who cannot join
- more than one ureteral calculi
- radiolucent stones or cystine stones
- prior ipsilateral calculus or ureteral surgery
- congenital anomalies of the ureter
- patients presents with an absolute indication for intervention
- allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP <90 mmHg)
Show all 9Show fewer
- patient currently taking an alpha-blocker
- hepatic insufficiency
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.
- Conditions
- Kidney Stones
- Being tested
- Alfuzosin (Xatral), Placebo Alfuzosin
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin (Xatral)Drug
10 mg PO once a day
Placebo AlfuzosinDrug
10 mg PO once a day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Alfuzosin (Xatral) |
| B | Placebo comparator | Not described Receives: Drug: Placebo Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
Measured: 4 weeks
Secondary outcomes (1)
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionOct 2009
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.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Kenneth A Pace, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583258
- Sponsor's protocol ID
- SMHXATRAL2007
- Other IDs
- ALFUS-L-00811
- Status last verified
- Jul 2015
- First submitted
- 20 Dec 2007
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
- ClinicalTrials.gov ID
- NCT00583258
- Acronym / sponsor ID
- SMHXATRAL2007
- Conditions
- Kidney Stones
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Dec 2007 (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.
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Alfuzosin (Xatral) |
| B | Placebo comparator | Drug: Placebo Alfuzosin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
- stone radiopaque on KUB, distal to the sacro-iliac joint
- patient suitable for discharge from ER
- patient willing to return for follow-up on a weekly basis for maximum 4 visits
Key exclusion criteria (9 listed)
- more than one ureteral calculi
- radiolucent stones or cystine stones
- prior ipsilateral calculus or ureteral surgery
- congenital anomalies of the ureter
- patients presents with an absolute indication for intervention
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 |
|---|---|---|
| Alfuzosin (Xatral)10 mg PO once a day | Drug | A |
| Placebo Alfuzosin10 mg PO once a day | Drug | B |
Primary outcome
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
Time frame: 4 weeks
1 secondary outcome
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
Time frame: 4 weeks
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 31 Jul 2015.
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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.
Kenneth A Pace, MD, FRCSC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfuzosin (Xatral) in people with Kidney Stones, run by Unity Health Toronto at 1 site in Canada.
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 9 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 31 Jul 2015. 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 Canada. 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.
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?
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time (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 31 Jul 2015.