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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00209131
Other study ID # 0128-2005
Secondary ID
Status Terminated
Phase N/A
First received September 14, 2005
Last updated September 23, 2013
Start date April 2005
Est. completion date February 2009

Study information

Verified date September 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.


Description:

Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

Exclusion Criteria:

- Contraindications to Flomax

- Patients with renal impairment (serum creatinine above 2.0)

- Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)

- Use of other oral alpha blockers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Flomax
0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
Sugar pill
Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.

Locations

Country Name City State
United States Emory University Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Passage of Stone Fragments Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging. 2 weeks and 3 months No
Secondary Medical Evaluation Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures. 2 weeks and 3 months Yes
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