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Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by United States Naval Medical Center, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sean Stroup, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT00713739
First received: July 7, 2008
Last updated: April 25, 2012
Last verified: April 2012

July 7, 2008
April 25, 2012
January 2008
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00713739 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Alfuzosin for Medical Expulsion Therapy of Ureteral Stones
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Stones
  • Drug: Alfuzosin
    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.
  • Drug: nifedipine
    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.
  • Drug: doxazosin
    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.
  • Drug: prazosin
    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.
  • Experimental: 1
    Alfuzosin 10mg daily
    Intervention: Drug: Alfuzosin
  • Active Comparator: 2
    Nifedipine XL 30mg daily
    Intervention: Drug: nifedipine
  • Active Comparator: 3
    Doxazosin 4 mg daily
    Intervention: Drug: doxazosin
  • Active Comparator: 4
    Prazosin 1 mg BID
    Intervention: Drug: prazosin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Brian K. Auge, M.D. 619-532-7200
Contact: Sean P. Stroup, M.D. 619-532-7200
United States
 
NCT00713739
NMCSD CID 06-050, Office of Naval Research FY08
Yes
Sean Stroup, United States Naval Medical Center, San Diego
United States Naval Medical Center, San Diego
Not Provided
Principal Investigator: Brian K. Auge, M.D. NMCSD
Principal Investigator: Sean P. Stroup, M.D. NMCSD
United States Naval Medical Center, San Diego
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP