- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713739
Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)
April 25, 2012 updated by: Sean Stroup, United States Naval Medical Center, San Diego
Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Recruiting
- Naval Medical Center San Diego
-
Contact:
- Sean P. Stroup, M.D.
- Phone Number: 619-532-7200
-
Contact:
- Brian K Auge, M.D.
- Phone Number: 619-532-7200
-
Principal Investigator:
- Brian K. Auge, M.D.
-
Principal Investigator:
- Sean P. Stroup, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Alfuzosin 10mg daily
|
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.
|
Active Comparator: 2
Nifedipine XL 30mg daily
|
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.
|
Active Comparator: 3
Doxazosin 4 mg daily
|
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.
|
Active Comparator: 4
Prazosin 1 mg BID
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Period of stone passage (30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian K. Auge, M.D., NMCSD
- Principal Investigator: Sean P. Stroup, M.D., NMCSD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
July 7, 2008
First Submitted That Met QC Criteria
July 7, 2008
First Posted (Estimate)
July 11, 2008
Study Record Updates
Last Update Posted (Estimate)
April 27, 2012
Last Update Submitted That Met QC Criteria
April 25, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Ureteral Diseases
- Urolithiasis
- Urinary Calculi
- Calculi
- Kidney Calculi
- Nephrolithiasis
- Ureteral Calculi
- Ureterolithiasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Urological Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Alfuzosin
- Nifedipine
- Prazosin
- Doxazosin
Other Study ID Numbers
- NMCSD CID 06-050
- Office of Naval Research FY08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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