Study of Silodosin to Facilitate Passage of Urinary Stones

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

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Detailed Description

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Conditions

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Ureteral Calculi Kidney Stones Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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silodsosin

Group Type ACTIVE_COMPARATOR

silodosin

Intervention Type DRUG

one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one placebo capsule orally, once daily, with food for up to 4 weeks

Interventions

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silodosin

one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks

Intervention Type DRUG

placebo

one placebo capsule orally, once daily, with food for up to 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age or older
* Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
* Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Exclusion Criteria

* Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
* History of previous ureteral surgery or ureteral stricture on affected side
* History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
* Moderate to severe renal impairment or severe liver insufficiency
* History of significant postural hypotension
* Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
* History of allergy to alpha-blockers or oxycodone

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No