| January 14, 2008 |
| January 14, 2008 |
| August 2006 |
| November 2007 (final data collection date for primary outcome measure) |
| Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- Time to spontaneous ureteral stone expulsion. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
- Self-reported NRS-11 pain scores. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
- Number of colicky pain episodes. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
- Number of days missed work or usual functional ability. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
- Number of return ED visits or unscheduled PCP visits for continued pain. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
- Amount of narcotic pain medication used. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: Yes ]
- Adverse medication-related events. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients |
| The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Nephrolithiasis
- Ureteral Calculi
|
- Drug: tamsulosin
- Drug: Standard therapy with ibuprofen and oxycodone.
|
- Experimental: Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
- Other: Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
|
| |
| |
| Completed |
| 81 |
| November 2007 |
| November 2007 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00600405 |
| Andrew Perron, MD, Maine Medical Center |
| 2958 |
| Maine Medical Center |
| Maine Medical Center Mentored Research Committee |
| Principal Investigator: |
Andrew D Perron, MD |
Maine Medical Center |
|
|
| Maine Medical Center |
| January 2008 |