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

NCT ID: NCT01539265

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Urinary Calculus

Keywords

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urinary calculus ureteral stones medical expulsive therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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silodosin, arm 1

Group Type EXPERIMENTAL

silodosin

Intervention Type DRUG

silodosin, arm 2

Group Type EXPERIMENTAL

silodosin

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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silodosin

Intervention Type DRUG

silodosin

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatsuro Takei

Role: STUDY_DIRECTOR

Clinical Development Department, Kissei pharmaceutical Co., Ltd.

Locations

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Japan

Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KMD3201

Identifier Type: -

Identifier Source: org_study_id