Back to resultsA Dose-finding Study of Silodosin in Patients With Urinary Calculi
Primary Purpose
Urinary Calculus
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
silodosin
silodosin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Calculus focused on measuring urinary calculus, ureteral stones, medical expulsive therapy
Eligibility Criteria
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.
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
silodosin, arm 1
silodosin, arm 2
placebo
Arm Description
Outcomes
Primary Outcome Measures
Spontaneous stone passage rate
Secondary Outcome Measures
Time to spontaneous stone passage
Analgesic use
Pain severity
Full Information
NCT ID
NCT01539265
First Posted
February 21, 2012
Last Updated
October 29, 2013
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01539265
Brief Title
A Dose-finding Study of Silodosin in Patients With Urinary Calculi
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculus
Keywords
urinary calculus, ureteral stones, medical expulsive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Arm Title
silodosin, arm 1
Arm Type
Experimental
Arm Title
silodosin, arm 2
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
silodosin
Intervention Type
Drug
Intervention Name(s)
silodosin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Spontaneous stone passage rate
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Time to spontaneous stone passage
Time Frame
4 weeks
Title
Analgesic use
Time Frame
4 weeks
Title
Pain severity
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuro Takei
Organizational Affiliation
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Dose-finding Study of Silodosin in Patients With Urinary Calculi
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