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NCT00382265 · ClinicalTrials.gov registry record · Phase 4
Tamsulosin for Urolithiasis in the Emergency Dept
A Phase 4 study of Ureterolithiases, sponsored by Andrew Meltzer.
- Completed
- Registry status
- Phase 4
- Development phase
- 512
- Enrollment target
- 4
- Study locations
NCT00382265 is a Phase 4 study of Ureterolithiases that has completed, run by Andrew Meltzer. The registered enrollment target is 512 participants. The trial reports 4 study locations across 3 states.
The verdict
NCT00382265, a Phase 4 study of Ureterolithiases, has completed, sponsored by Andrew Meltzer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 512 participants
- Enrollment target
- 4
- Study locations
Study Summary
Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients. Based on encouraging results from several small European clinical studies, the researchers hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. The researchers will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions. A total of 500 consenting subjects will be randomly assigned to one of two groups: 1. tamsulosin for a maximum of 28 days; 2. placebo for a maximum of 28 days. In addition, both groups will receive standard analgesic therapy. The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome. The primary objectives of this study are: 1. to determine if tamsulosin is effective, and 2. to evaluate the safety of the therapy. Another objective is to identify the most appropriate clinical subgroup(s) for treatment. If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including: 1. a reduction in time to pain free recovery and hence a more rapid return to employment; 2. decreased requirements for narcotic analgesia; 3. less need for urological out-patient clinic follow-up; 4. decreased need for surgical intervention or lithotripsy; and 5. substantial cost savings. If this the
Conditions Studied
Interventions
- OTHER Placebo
- DRUG tamsulosin
Study Locations (4)
Pennsylvania
- Thomas Jefferson University - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama - Birmingham - Birmingham
District of Columbia
- The George Washington University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2008-01 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382265
The ClinicalTrials.gov registry entry for NCT00382265 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrew Meltzer, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ureterolithiases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00382265 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Alabama, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00382265 about?
NCT00382265 is a clinical study titled "Tamsulosin for Urolithiasis in the Emergency Dept". Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work da...
What is the current status of trial NCT00382265?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 512 participants. The study started on 2008-01. Estimated completion is 2017-02-01.
What conditions does trial NCT00382265 study?
This clinical trial studies the following conditions: Ureterolithiases.
What interventions are being tested in trial NCT00382265?
The interventions under investigation include: Placebo (OTHER), tamsulosin (DRUG).
Who is sponsoring clinical trial NCT00382265?
This trial is sponsored by Andrew Meltzer, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00382265 being conducted?
This trial has 4 study locations across Alabama, District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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