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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00600405
Other study ID # 2958
Secondary ID
Status Completed
Phase N/A
First received January 14, 2008
Last updated January 14, 2008
Start date August 2006
Est. completion date November 2007

Study information

Verified date January 2008
Source Maine Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
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.

Locations

Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (2)

Lead Sponsor Collaborator
Maine Medical Center Maine Medical Center Mentored Research Committee

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of spontaneous ureteral stone expulsion 48, 120, 336 hours No
Secondary Time to spontaneous ureteral stone expulsion. 48, 120, 336 hours No
Secondary Self-reported NRS-11 pain scores. 48, 120, 336 hours No
Secondary Number of colicky pain episodes. 48, 120, 336 hours No
Secondary Number of days missed work or usual functional ability. 48, 120, 336 hours No
Secondary Number of return ED visits or unscheduled PCP visits for continued pain. 48, 120, 336 hours No
Secondary Amount of narcotic pain medication used. 48, 120, 336 hours Yes
Secondary Adverse medication-related events. 48, 120, 336 hours Yes
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