Urinary Calculus
Conditions
Keywords
urinary calculus, ureteral stones, medical expulsive therapy
Brief summary
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
Interventions
DRUGsilodosin
DRUGplacebo
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous stone passage rate | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to spontaneous stone passage | 4 weeks |
| Analgesic use | 4 weeks |
| Pain severity | 4 weeks |
Countries
Japan
Outcome results
None listed