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Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)

Primary Purpose

Kidney Stones

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alfuzosin
nifedipine
doxazosin
prazosin
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring kidney stones, ureteral stones, medical expulsion therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age >/= 18 years
  • Single ureteral stone < 1 cm in greatest dimension

Exclusion Criteria:

  • Age < 18 years
  • Active unstable angina
  • History of or active postural hypotension (>20 mmHg drop in orthostatic SBP)
  • Allergy to alpha-blockers
  • Acute or Chronic Renal Failure as demonstrated by a serum creatinine of > 1.4 mg/dl
  • Urinary tract infection
  • Multiple ureteral stones
  • Current uncontrolled diabetes
  • Alpha-blocker therapy within 30 days for any reason
  • Current pregnancy or lactation
  • Patient desire for immediate stone removal

Sites / Locations

  • Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Alfuzosin 10mg daily

Nifedipine XL 30mg daily

Doxazosin 4 mg daily

Prazosin 1 mg BID

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
April 25, 2012
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00713739
Brief Title
Alfuzosin for Medical Expulsion Therapy of Ureteral Stones
Acronym
MET
Official Title
Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
kidney stones, ureteral stones, medical expulsion therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Alfuzosin 10mg daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
Nifedipine XL 30mg daily
Arm Title
3
Arm Type
Active Comparator
Arm Description
Doxazosin 4 mg daily
Arm Title
4
Arm Type
Active Comparator
Arm Description
Prazosin 1 mg BID
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Intervention Description
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
Intervention Type
Drug
Intervention Name(s)
nifedipine
Intervention Description
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
Intervention Type
Drug
Intervention Name(s)
doxazosin
Intervention Description
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
Intervention Type
Drug
Intervention Name(s)
prazosin
Intervention Description
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >/= 18 years Single ureteral stone < 1 cm in greatest dimension Exclusion Criteria: Age < 18 years Active unstable angina History of or active postural hypotension (>20 mmHg drop in orthostatic SBP) Allergy to alpha-blockers Acute or Chronic Renal Failure as demonstrated by a serum creatinine of > 1.4 mg/dl Urinary tract infection Multiple ureteral stones Current uncontrolled diabetes Alpha-blocker therapy within 30 days for any reason Current pregnancy or lactation Patient desire for immediate stone removal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian K. Auge, M.D.
Phone
619-532-7200
First Name & Middle Initial & Last Name or Official Title & Degree
Sean P. Stroup, M.D.
Phone
619-532-7200
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian K. Auge, M.D.
Organizational Affiliation
NMCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean P. Stroup, M.D.
Organizational Affiliation
NMCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian K Auge, M.D.
Phone
619-532-7200
First Name & Middle Initial & Last Name & Degree
Sean P. Stroup, M.D.
Phone
619-532-7200
First Name & Middle Initial & Last Name & Degree
Brian K. Auge, M.D.
First Name & Middle Initial & Last Name & Degree
Sean P. Stroup, M.D.

12. IPD Sharing Statement

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Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

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