UrolithiasisNCT00209131
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
A study testing Flomax and Sugar pill in people with Urolithiasis, run by Emory University at 1 site in United States.
Trial summary
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Flomax and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.
Who cannot join
- Contraindications to Flomax
- Patients with renal impairment (serum creatinine above 2.0)
- Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
- Use of other oral alpha blockers
Trial locations and contacts
1 site in 1 country.
About this study
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
Read the detailed description
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
- Conditions
- Urolithiasis
- Being tested
- Flomax, Sugar pill
- Keywords
- urolithiasis
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlomaxDrug
Also called Tamsulosin
0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
Sugar pillDrug
Also called Placebo pill
Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
| Study group | Role | What they receive |
|---|---|---|
| Flomax | Experimental | Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. Receives: Drug: Flomax |
| Sugar pill | Placebo comparator | Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Passage of Stone Fragments
Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.
Measured: 2 weeks and 3 months
Secondary outcomes (1)
Medical Evaluation
Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.
Measured: 2 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Due to frequent turnover of research coordinators and thus poor study accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Ogan, MD, Emory University
- Investigators
- Kenneth Ogan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209131
- Sponsor's protocol ID
- 0128-2005
- Status last verified
- Sep 2013
- First submitted
- 14 Sep 2005
- Last updated
- 28 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
- ClinicalTrials.gov ID
- NCT00209131
- Acronym / sponsor ID
- 0128-2005
- Conditions
- Urolithiasis
- Keywords
- urolithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to frequent turnover of research coordinators and thus poor study accrual.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 9 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
Detailed description
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flomax | Experimental | Drug: FlomaxPatients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. |
| Sugar pill | Placebo comparator | Drug: Sugar pillPatients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.
Key exclusion criteria (4 listed)
- Contraindications to Flomax
- Patients with renal impairment (serum creatinine above 2.0)
- Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
- Use of other oral alpha blockers
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 |
|---|---|---|
| FlomaxAlso: Tamsulosin0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage. | Drug | Flomax |
| Sugar pillAlso: Placebo pillComparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage. | Drug | Sugar pill |
Primary outcome
Time to Passage of Stone Fragments
Time frame: 2 weeks and 3 months
Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.
1 secondary outcome
Medical Evaluation
Time frame: 2 weeks and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Ogan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flomax and Sugar pill in people with Urolithiasis, run by Emory University 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 1 inclusion and 4 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 28 Oct 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Passage of Stone Fragments (time frame: 2 weeks and 3 months). 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 28 Oct 2013.