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

Kissei

Status and phase: Completed; Phase 2

Conditions: Urinary Calculus

Treatments: Drug: silodosin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539265

KMD3201

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 3 patient groups, including a placebo group

silodosin, arm 1

Experimental group

Treatment:

Drug: silodosin

Drug: silodosin

silodosin, arm 2

Experimental group

Treatment:

Drug: silodosin

Drug: silodosin

placebo

Placebo Comparator group

Treatment:

Drug: placebo