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Sponsored by: |
William Beaumont Hospitals |
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Information provided by: | William Beaumont Hospitals |
ClinicalTrials.gov Identifier: | NCT00448123 |
To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.
Condition | Intervention |
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Kidney Stones Ureteral Stones |
Drug: Tamsulosin (Flomax) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
Official Title: | The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients |
Estimated Enrollment: | 378 |
Study Start Date: | February 2007 |
This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital.
Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review.
The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).
Study exclusion criteria:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrick B Medado, BS | 248-898-0124 | pmedado@beaumonthospitals.com |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Principal Investigator: Kelsea Lipe, MD | |
Sub-Investigator: Andrew Bernstein, MD | |
Sub-Investigator: Jay Hollander, Md | |
Sub-Investigator: Raymond Jackson, MD | |
Sub-Investigator: Brian Seifman, MD | |
Sub-Investigator: Nathan Pickering, MD |
Principal Investigator: | Kelsea Lipe, MD | William Beaumont Hospitals |
Study ID Numbers: | 2005-107 |
Study First Received: | March 13, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00448123 |
Health Authority: | United States: Institutional Review Board |
Kidney Stones Ureteral Stones Flomax Emergency Medicine Urology |
Pathological Conditions, Anatomical Urinary Calculi Urolithiasis Ureteral Calculi Ureteral Diseases Calculi Ureterolithiasis |
Urologic Diseases Tamsulosin Emergencies Kidney Diseases Nephrolithiasis Kidney Calculi |
Neurotransmitter Agents Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adrenergic Antagonists Adrenergic alpha-Antagonists Pharmacologic Actions |