Status:
COMPLETED
Study of Silodosin to Facilitate Passage of Urinary Stones
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Ureteral Calculi
Kidney Stones
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01144949
Start Date
June 1 2010
End Date
July 1 2012
Last Update
August 11 2014
Active Locations (27)
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1
Watson Investigational Site
Birmingham, Alabama, United States
2
Watson Investigational Site
Anchorage, Alaska, United States
3
Watson Investigative Site
Mission Hills, California, United States
4
Watson Investigational Site
Murrieta, California, United States