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

Urinary Calculus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539265
• Other study ID #: KMD3201
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2012
• Last updated: October 29, 2013

Study information

• Verified date: October 2013
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urinary Calculus

Intervention

Drug:
• silodosin

• silodosin

• placebo

Locations

Country	Name	City	State
Japan	Japan	Tokyo and Other Japanese City

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous stone passage rate		4 weeks	No
Secondary	Time to spontaneous stone passage		4 weeks	No
Secondary	Analgesic use		4 weeks	No
Secondary	Pain severity		4 weeks	No