Study of Silodosin to Facilitate Passage of Urinary Stones

Watson Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Urolithiasis

Ureteral Calculi

Kidney Stones

Treatments

Drug: placebo

Drug: silodosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01144949

SIL1001

Details and patient eligibility

About

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.

Enrollment

239 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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