Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)
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| First Received Date ICMJE | July 7, 2008 | ||||||||
| Last Updated Date | April 25, 2012 | ||||||||
| Start Date ICMJE | January 2008 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary measures are percent of stones passed and rates of occurrence of various side effects (categorical variables), and time to pass, pain scale, and amount of pain medication taken (continuous variables). [ Time Frame: Period of stone passage (30 days) ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00713739 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alfuzosin for Medical Expulsion Therapy of Ureteral Stones | ||||||||
| Official Title ICMJE | Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones | ||||||||
| Brief Summary | The goal of this study is to conduct a prospective controlled trail of four currently approved Department of Defense (DOD) - formulary medications for use as medical expulsion therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic urolithiasis in there life. Several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal ureteral calculi. None of these studies have been widely publicized outside the specialty of urology. Recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. The investigators will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications. |
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| Detailed Description | Patients presenting to Naval Medical Center San Diego with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. Upon consent, patients will be randomly assigned to one of four outpatient treatment arms, randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg twice daily. The primary endpoint is stone expulsion rate and secondary endpoints are time to expulsion, need for additional intervention, degree of pain control, amount of narcotic use, and evaluation of study drug side effects. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Kidney Stones | ||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00713739 | ||||||||
| Other Study ID Numbers ICMJE | NMCSD CID 06-050, Office of Naval Research FY08 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sean Stroup, United States Naval Medical Center, San Diego | ||||||||
| Study Sponsor ICMJE | United States Naval Medical Center, San Diego | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | United States Naval Medical Center, San Diego | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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