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
  Purpose

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.


Condition Intervention Phase
Kidney Stones
Drug: Alfuzosin
Drug: nifedipine
Drug: doxazosin
Drug: prazosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

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). [ Time Frame: Period of stone passage (30 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Alfuzosin 10mg daily
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.
Active Comparator: 2
Nifedipine XL 30mg daily
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.
Active Comparator: 3
Doxazosin 4 mg daily
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.
Active Comparator: 4
Prazosin 1 mg BID
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713739

Contacts
Contact: Brian K. Auge, M.D. 619-532-7200
Contact: Sean P. Stroup, M.D. 619-532-7200

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Brian K Auge, M.D.    619-532-7200      
Contact: Sean P. Stroup, M.D.    619-532-7200      
Principal Investigator: Brian K. Auge, M.D.         
Principal Investigator: Sean P. Stroup, M.D.         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Brian K. Auge, M.D. NMCSD
Principal Investigator: Sean P. Stroup, M.D. NMCSD
  More Information

No publications provided

Responsible Party: Sean Stroup, Principle Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT00713739     History of Changes
Other Study ID Numbers: NMCSD CID 06-050, Office of Naval Research FY08
Study First Received: July 7, 2008
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
kidney stones
ureteral stones
medical expulsion therapy

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Nifedipine
Prazosin
Alfuzosin
Doxazosin
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 22, 2014