Study of Silodosin to Facilitate Passage of Urinary Stones

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Silodosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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