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NCT02369744 · ClinicalTrials.gov registry record · Phase 4
Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
A Phase 4 study, sponsored by Albert Einstein Healthcare Network.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02369744 is a Phase 4 study that was terminated before completion, run by Albert Einstein Healthcare Network. The registered enrollment target is 1 participants.
The verdict
NCT02369744, a Phase 4 study, was terminated before completion, sponsored by Albert Einstein Healthcare Network.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certain conditions and the patient isn't too sick, the patient is usually sent home to try and pass the stone without surgery. This treatment is known as medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin, which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a drug in the same class of tamsulosin, but which is thought to have a more selective action and a quicker onset, which would theoretically make it better for aiding in kidney stone passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs to see how quickly they result in stone passage. Subjects are patients presenting to the ED with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is that silodosin will have decreased time to stone passage compared to tamsulosin. Subjects who qualify and consent are randomized to a two-week course of either silodosin or tamsulosin. They are also given prescriptions for standard of care medications for pain and nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind them of their follow-up appointment, ask about adverse events, and determine if their stone has passed. They have a follow-up visit with study staff at the end of their two week treatment to collect their pain diary, pill count, adverse events, and to determine if their stone has passed. Study participation ends after this follow-up visit.
Interventions
- DRUG Tamsulosin
- DRUG Silodosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02369744
The ClinicalTrials.gov registry entry for NCT02369744 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein Healthcare Network, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tamsulosin is the first listed.
NCT02369744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02369744 about?
NCT02369744 is a clinical study titled "Silodosin Versus Tamsulosin for Treatment of Ureteral Stones". Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certa...
What is the current status of trial NCT02369744?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2013-03. Estimated completion is 2013-10.
What interventions are being tested in trial NCT02369744?
The interventions under investigation include: Tamsulosin (DRUG), Silodosin (DRUG).
Who is sponsoring clinical trial NCT02369744?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
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