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Sponsors and Collaborators: |
Maine Medical Center Maine Medical Center Mentored Research Committee |
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Information provided by: | Maine Medical Center |
ClinicalTrials.gov Identifier: | NCT00600405 |
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.
Condition | Intervention |
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Nephrolithiasis Ureteral Calculi |
Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone. |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients |
Enrollment: | 81 |
Study Start Date: | August 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
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Drug: tamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
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II
Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
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Drug: 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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maine | |
Maine Medical Center | |
Portland, Maine, United States, 04102 |
Principal Investigator: | Andrew D Perron, MD | Maine Medical Center |
Responsible Party: | Maine Medical Center ( Andrew Perron, MD ) |
Study ID Numbers: | 2958 |
Study First Received: | January 14, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600405 |
Health Authority: | United States: Institutional Review Board |
Nephrolithiasis Ureteral Calculi |
Pathological Conditions, Anatomical Urinary Calculi Ibuprofen Urolithiasis Oxycodone Ureteral Calculi Ureteral Diseases |
Calculi Ureterolithiasis Urologic Diseases Tamsulosin Emergencies Kidney Diseases Nephrolithiasis |
Anti-Inflammatory Agents Neurotransmitter Agents Disease Attributes Adrenergic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Central Nervous System Depressants Narcotics Enzyme Inhibitors Adrenergic alpha-Antagonists |
Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Adrenergic Antagonists Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |