The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
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|ClinicalTrials.gov Identifier: NCT00600405|
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Nephrolithiasis Ureteral Calculi||Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
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.
- Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ]
- Time to spontaneous ureteral stone expulsion. [ Time Frame: 48, 120, 336 hours ]
- Self-reported NRS-11 pain scores. [ Time Frame: 48, 120, 336 hours ]
- Number of colicky pain episodes. [ Time Frame: 48, 120, 336 hours ]
- Number of days missed work or usual functional ability. [ Time Frame: 48, 120, 336 hours ]
- Number of return ED visits or unscheduled PCP visits for continued pain. [ Time Frame: 48, 120, 336 hours ]
- Amount of narcotic pain medication used. [ Time Frame: 48, 120, 336 hours ]
- Adverse medication-related events. [ Time Frame: 48, 120, 336 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT00600405
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Andrew D Perron, MD||Maine Medical Center|