A Dose-finding Study of Silodosin in Patients With Urinary Calculi

A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi

The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.

Inclusion Criteria:

• Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
• Patients who are able to visit the site continually as out-patient during the study

Exclusion Criteria:

• Patients who have multiple urethral stones.
• Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
• Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
• Patients who have a clinically significant hepatic or renal disorder.
• Patients with postural hypotension or with a history of postural hypotension.
• Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
• Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.