NephrolithiasisNCT00600405
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
A study testing tamsulosin and Standard therapy with ibuprofen and oxycodone. in people with Nephrolithiasis and Ureteral Calculi, run by MaineHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Ureteral Calculi
- What is being tested?
- tamsulosin and Standard therapy with ibuprofen and oxycodone.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- able to read, write, and speak English;
- able to use the NRS pain scale; and
- computed tomography diagnosed single lower ureteral calculus
Who cannot join
- allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);
- sulfa/sulfonamide allergy;
- inability to provide informed consent;
- lithiasis of the ureteral intramural tract;
- acute or chronic renal failure;
- fever;
Show all 13Show fewer
- presence of multiple ureteral stones;
- peptic ulcer disease;
- liver failure;
- concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
- pregnancy;
- breastfeeding; or
- a history of urinary surgery or endoscopic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.
Read the detailed description
This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.
- Conditions
- Nephrolithiasis, Ureteral Calculi
- Being tested
- tamsulosin, Standard therapy with ibuprofen and oxycodone.
- Keywords
- Nephrolithiasis, Ureteral Calculi
- Medical subject headings
- Nephrolithiasis, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosinDrug
Also called Flomax
Tamsulosin 0.4 mg orally daily for ten days.
Standard therapy with ibuprofen and oxycodone.Drug
Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days. Receives: Drug: tamsulosin |
| II | Other | Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone. Receives: Drug: Standard therapy with ibuprofen and oxycodone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of spontaneous ureteral stone expulsion
Measured: 48, 120, 336 hours
Secondary outcomes (7)
Time to spontaneous ureteral stone expulsion.
Measured: 48, 120, 336 hours
Self-reported NRS-11 pain scores.
Measured: 48, 120, 336 hours
Number of colicky pain episodes.
Measured: 48, 120, 336 hours
Number of days missed work or usual functional ability.
Measured: 48, 120, 336 hours
Number of return ED visits or unscheduled PCP visits for continued pain.
Measured: 48, 120, 336 hours
Amount of narcotic pain medication used.
Measured: 48, 120, 336 hours
Adverse medication-related events.
Measured: 48, 120, 336 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Maine Medical Center Mentored Research Committee
- Investigators
- Andrew D Perron, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600405
- Sponsor's protocol ID
- 2958
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00600405
- Acronym / sponsor ID
- 2958
- Conditions
- Nephrolithiasis, Ureteral Calculi
- Keywords
- Nephrolithiasis, Ureteral Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Maine Medical Center Mentored Research Committee
- Study start
- Aug 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Jan 2008 (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.
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.
Detailed description
This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: tamsulosinSubjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days. |
| II | Other | Drug: Standard therapy with ibuprofen and oxycodone.Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- able to read, write, and speak English;
- able to use the NRS pain scale; and
- computed tomography diagnosed single lower ureteral calculus
Key exclusion criteria (13 listed)
- allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);
- sulfa/sulfonamide allergy;
- inability to provide informed consent;
- lithiasis of the ureteral intramural tract;
- acute or chronic renal failure;
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 |
|---|---|---|
| tamsulosinAlso: FlomaxTamsulosin 0.4 mg orally daily for ten days. | Drug | I |
| Standard therapy with ibuprofen and oxycodone.Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain. | Drug | II |
Primary outcome
Rate of spontaneous ureteral stone expulsion
Time frame: 48, 120, 336 hours
7 secondary outcomes
Time to spontaneous ureteral stone expulsion.
Time frame: 48, 120, 336 hours
Self-reported NRS-11 pain scores.
Time frame: 48, 120, 336 hours
Number of colicky pain episodes.
Time frame: 48, 120, 336 hours
Number of days missed work or usual functional ability.
Time frame: 48, 120, 336 hours
Number of return ED visits or unscheduled PCP visits for continued pain.
Time frame: 48, 120, 336 hours
Amount of narcotic pain medication used.
Time frame: 48, 120, 336 hours
Adverse medication-related events.
Time frame: 48, 120, 336 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
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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.
Andrew D Perron, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tamsulosin and Standard therapy with ibuprofen and oxycodone. in people with Nephrolithiasis and Ureteral Calculi, run by MaineHealth 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 4 inclusion and 13 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 25 Jan 2008. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of spontaneous ureteral stone expulsion (time frame: 48, 120, 336 hours). 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 25 Jan 2008.