A Dose-finding Study of Silodosin in Patients With Urinary Calculi
- Registration Number
- NCT01539265
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - silodosin, arm 2 silodosin - silodosin, arm 1 silodosin -
- Primary Outcome Measures
Name Time Method Spontaneous stone passage rate 4 weeks
- Secondary Outcome Measures
Name Time Method Pain severity 4 weeks Time to spontaneous stone passage 4 weeks Analgesic use 4 weeks
Trial Locations
- Locations (1)
Japan
🇯🇵Tokyo and Other Japanese City, Japan