Clinical trial NCT01144949: Study of Silodosin to Facilitate Passage of Urinary Stones
Official title: A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureteral Calculi
Kidney Stones
Urolithiasis
Keywords: ureteral calculi
renal colic
ureteral stones
kidney stones
medical expulsive therapy
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
timeFrame: 4 weeks
measure: Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to Spontaneous Stone Passage (Distal Stones)
timeFrame: 4 weeks
measure: Outpatient Narcotic Analgesic Use for Pain Relief
timeFrame: 4 weeks
measure: Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
timeFrame: 4 weeks
measure: Time to Spontaneous Stone Passage (All Stones)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Watson Investigational Site
state: Alabama
city: Anchorage
country: United States
facility: Watson Investigational Site
state: Alaska
city: Mission Hills
country: United States
facility: Watson Investigative Site
state: California
city: Murrieta
country: United States
facility: Watson Investigational Site
state: California
city: San Diego
country: United States
facility: Watson Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Watson Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Watson Investigational Site
state: Florida
city: Orange City
country: United States
facility: Watson Investigational Site
state: Florida
city: Overland Park
country: United States
facility: Watson Investigative Site
state: Kansas
city: North Kansas City
country: United States
facility: Watson Investigative Site
state: Missouri
city: Hackensack
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Mt Laurel
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Sewell
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Watson Investigational Site
state: New York
city: Garden City
country: United States
facility: Watson Investigational Site
state: New York
city: New York
country: United States
facility: Watson Investigational Site
state: New York
city: Plainview
country: United States
facility: Watson Investigational Site
state: New York
city: Syracuse
country: United States
facility: Watson Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Watson Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Watson Investigational Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Watson Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Watson Investigational Site
state: Texas
city: Virginia Beach
country: United States
facility: Watson Investigational Site
state: Virginia
Study officials:
affiliation: Watson Pharmaceuticals, Inc.
name: Scott Olsen, MPH
role: STUDY_DIRECTOR
References: