Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

NCT00713739 | Unknown Phase 3 DMC

• 2 other identifiers: NMCSD CID 06-050Office of Naval Research FY08
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

kidney stones; ureteral stones; medical expulsion therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  Period of stone passage (30 days)

Study Arms (4)

1

EXPERIMENTAL

Alfuzosin 10mg daily

Drug: Alfuzosin

2

ACTIVE COMPARATOR

Nifedipine XL 30mg daily

Drug: nifedipine

3

ACTIVE COMPARATOR

Doxazosin 4 mg daily

Drug: doxazosin

4

ACTIVE COMPARATOR

Prazosin 1 mg BID

Drug: prazosin

Interventions

Alfuzosin DRUG

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.

1

nifedipine DRUG

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.

2

doxazosin DRUG

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.

3

prazosin DRUG

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.

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

alfuzosin; Nifedipine; Doxazosin; Prazosin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Brian K. Auge, M.D.

  NMCSD

  PRINCIPAL INVESTIGATOR

• Sean P. Stroup, M.D.

  NMCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian K. Auge, M.D.

CONTACT

619-532-7200

Sean P. Stroup, M.D.

CONTACT

619-532-7200

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 11, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

US (1)