Study of Silodosin to Facilitate Passage of Urinary Stones

Completed · Phase 2 · Has a placebo group

Conditions studied: Ureteral Calculi, Kidney Stones, Urolithiasis

In brief

The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Key facts

Study ID

NCT01144949

Run by

Watson Pharmaceuticals

People needed

239

Starts

2010-06-01

Expected to finish

2012-07-01

Last updated by the study team

2014-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age or older
• Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
• Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

You may not qualify if…

• Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
• History of previous ureteral surgery or ureteral stricture on affected side
• History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
• Moderate to severe renal impairment or severe liver insufficiency
• History of significant postural hypotension
• Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
• History of allergy to alpha-blockers or oxycodone

Where it is running

• Watson Investigational Site — Birmingham, Alabama, United States
• Watson Investigational Site — Anchorage, Alaska, United States
• Watson Investigative Site — Mission Hills, California, United States
• Watson Investigational Site — Murrieta, California, United States
• Watson Investigational Site — San Diego, California, United States
• Watson Investigational Site — Daytona Beach, Florida, United States
• Watson Investigational Site — Gainesville, Florida, United States
• Watson Investigational Site — Orange City, Florida, United States
• Watson Investigative Site — Overland Park, Kansas, United States
• Watson Investigative Site — North Kansas City, Missouri, United States
• Watson Investigational Site — Hackensack, New Jersey, United States
• Watson Investigational Site — Mount Laurel, New Jersey, United States
• Watson Investigational Site — Sewell, New Jersey, United States
• Watson Investigational Site — Voorhees Township, New Jersey, United States
• Watson Investigational Site — Albany, New York, United States
• Watson Investigational Site — Garden City, New York, United States
• Watson Investigational Site — New York, New York, United States
• Watson Investigational Site — Plainview, New York, United States
• Watson Investigational Site — Syracuse, New York, United States
• Watson Investigational Site — Cincinnati, Ohio, United States
• Watson Investigational Site — Columbus, Ohio, United States
• Watson Investigational Site — Bala-Cynwyd, Pennsylvania, United States
• Watson Investigational Site — Lancaster, Pennsylvania, United States
• Watson Investigational Site — Myrtle Beach, South Carolina, United States
• Watson Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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