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Trial record 9 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600405
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
Maine Medical Center Mentored Research Committee
Information provided by:
Maine Medical Center

Brief 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. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Ureteral Calculi Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Study Start Date : August 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Experimental: I
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
Drug: tamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
Other Name: Flomax

Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
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.

Primary Outcome Measures :
  1. Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ]

Secondary Outcome Measures :
  1. Time to spontaneous ureteral stone expulsion. [ Time Frame: 48, 120, 336 hours ]
  2. Self-reported NRS-11 pain scores. [ Time Frame: 48, 120, 336 hours ]
  3. Number of colicky pain episodes. [ Time Frame: 48, 120, 336 hours ]
  4. Number of days missed work or usual functional ability. [ Time Frame: 48, 120, 336 hours ]
  5. Number of return ED visits or unscheduled PCP visits for continued pain. [ Time Frame: 48, 120, 336 hours ]
  6. Amount of narcotic pain medication used. [ Time Frame: 48, 120, 336 hours ]
  7. Adverse medication-related events. [ Time Frame: 48, 120, 336 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600405

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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center
Maine Medical Center Mentored Research Committee
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Principal Investigator: Andrew D Perron, MD Maine Medical Center

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Responsible Party: Andrew Perron, MD, Maine Medical Center Identifier: NCT00600405     History of Changes
Other Study ID Numbers: 2958
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by Maine Medical Center:
Ureteral Calculi
Additional relevant MeSH terms:
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Ureteral Calculi
Adrenergic Antagonists
Kidney Calculi
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Ureteral Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid