Kidney StoneFlowmaxNCT00762424
Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
A study testing Flowmax in people with Kidney Stone, run by WellSpan Health at 1 site in United States.
Trial summary
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Flowmax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2011
- 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
- 18 y.o. or older
- diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
- physician has made the decision that you will be discharged to home
- must be able to take study medication for up to 10 days and strain your urine
- must be able to keep a record of pain medication taken and complete a pain scale rating
Who cannot join
- patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
- patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
- patient known to have hypersensitivity to Tamsulosin
- patient history of cataract surgery
- inability of patient to perform visual pain scale
- allergy or intolerance to acetaminophen/oxycodone
- patient is unable to understand informed consent
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
York Hospital Emergency Department
York, Pennsylvania, 17405
About this study
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.
- Conditions
- Kidney Stone
- Being tested
- Flowmax, placebo
- Keywords
- Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department
- Medical subject headings
- Kidney Calculi, Ureterolithiasis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowmaxDrug
0.4 mg once a day until stone passage total = 9 tablets
placeboDrug
cornstarch
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | Not described Receives: Drug: Flowmax |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Stone Passage
Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionJan 2011
- Study completionJan 2011
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Pollack, MD, PhD, Principal investigator, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762424
- Sponsor's protocol ID
- 0607030
- Acronym
- Flowmax
- Status last verified
- Dec 2014
- First submitted
- 26 Sep 2008
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
- ClinicalTrials.gov ID
- NCT00762424
- Acronym / sponsor ID
- Flowmax / 0607030
- Conditions
- Kidney Stone
- Keywords
- Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 17 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: Flowmax |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 y.o. or older
- diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
- physician has made the decision that you will be discharged to home
- must be able to take study medication for up to 10 days and strain your urine
- must be able to keep a record of pain medication taken and complete a pain scale rating
Key exclusion criteria (8 listed)
- patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
- patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
- patient known to have hypersensitivity to Tamsulosin
- patient history of cataract surgery
- inability of patient to perform visual pain scale
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 |
|---|---|---|
| Flowmax0.4 mg once a day until stone passage total = 9 tablets | Drug | Tamsulosin |
| placebocornstarch | Drug | Placebo |
Primary outcome
Time of Stone Passage
Time frame: 10 Days
Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- 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.
Marc Pollack, MD, PhD principal investigator
WellSpan Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flowmax in people with Kidney Stone, run by WellSpan Health 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 5 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: finished, as of the sponsor's last update on 17 Dec 2014. 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 17 Dec 2014). 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 of Stone Passage (time frame: 10 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 17 Dec 2014.