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Study of Silodosin to Facilitate Passage of Urinary Stones

Primary Purpose

Ureteral Calculi, Kidney Stones, Urolithiasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
silodosin
placebo
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Calculi focused on measuring ureteral calculi, renal colic, ureteral stones, kidney stones, medical expulsive therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigative Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigative Site
  • Watson Investigative Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

silodsosin

placebo

Arm Description

Outcomes

Primary Outcome Measures

Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter.
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.

Secondary Outcome Measures

Time to Spontaneous Stone Passage (Distal Stones)
Time to stone passage for distally-located stones is assessed by entries in subject diaries.
Outpatient Narcotic Analgesic Use for Pain Relief
Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.
Time to Spontaneous Stone Passage (All Stones)
Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.

Full Information

First Posted
June 14, 2010
Last Updated
July 21, 2014
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01144949
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi, Kidney Stones, Urolithiasis
Keywords
ureteral calculi, renal colic, ureteral stones, kidney stones, medical expulsive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silodsosin
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
silodosin
Intervention Description
one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one placebo capsule orally, once daily, with food for up to 4 weeks
Primary Outcome Measure Information:
Title
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Description
The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter.
Time Frame
4 weeks
Title
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.
Description
The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Time to Spontaneous Stone Passage (Distal Stones)
Description
Time to stone passage for distally-located stones is assessed by entries in subject diaries.
Time Frame
4 weeks
Title
Outpatient Narcotic Analgesic Use for Pain Relief
Description
Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
Time Frame
4 weeks
Title
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)
Description
At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.
Time Frame
4 weeks
Title
Time to Spontaneous Stone Passage (All Stones)
Description
Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Olsen, MPH
Organizational Affiliation
Watson Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Watson Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Watson Investigational Site
City
Anchorage
State/Province
Alaska
Country
United States
Facility Name
Watson Investigative Site
City
Mission Hills
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
Murrieta
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Watson Investigative Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Watson Investigative Site
City
North Kansas City
State/Province
Missouri
Country
United States
Facility Name
Watson Investigational Site
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Mt Laurel
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Sewell
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Plainview
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Watson Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Watson Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Watson Investigational Site
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
Watson Investigational Site
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Watson Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Watson Investigational Site
City
Virginia Beach
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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Study of Silodosin to Facilitate Passage of Urinary Stones

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