Study of Silodosin to Facilitate Passage of Urinary Stones

A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis; Ureteral Calculi; Kidney Stones
• Intervention / Treatment: Drug: silodosin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Watson Investigational Site
  • Alaska
    • Anchorage, Alaska, United States
      • Watson Investigational Site
  • California
    • Mission Hills, California, United States
      • Watson Investigative Site
    • Murrieta, California, United States
      • Watson Investigational Site
    • San Diego, California, United States
      • Watson Investigational Site
  • Florida
    • Daytona Beach, Florida, United States
      • Watson Investigational Site
    • Gainesville, Florida, United States
      • Watson Investigational Site
    • Orange City, Florida, United States
      • Watson Investigational Site
  • Kansas
    • Overland Park, Kansas, United States
      • Watson Investigative Site
  • Missouri
    • North Kansas City, Missouri, United States
      • Watson Investigative Site
  • New Jersey
    • Hackensack, New Jersey, United States
      • Watson Investigational Site
    • Mt Laurel, New Jersey, United States
      • Watson Investigational Site
    • Sewell, New Jersey, United States
      • Watson Investigational Site
    • Voorhees, New Jersey, United States
      • Watson Investigational Site
  • New York
    • Albany, New York, United States
      • Watson Investigational Site
    • Garden City, New York, United States
      • Watson Investigational Site
    • New York, New York, United States
      • Watson Investigational Site
    • Plainview, New York, United States
      • Watson Investigational Site
    • Syracuse, New York, United States
      • Watson Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Watson Investigational Site
    • Columbus, Ohio, United States
      • Watson Investigational Site
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States
      • Watson Investigational Site
    • Lancaster, Pennsylvania, United States
      • Watson Investigational Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States
      • Watson Investigational Site
  • Texas
    • Dallas, Texas, United States
      • Watson Investigational Site
    • San Antonio, Texas, United States
      • Watson Investigational Site
  • Virginia
    • Virginia Beach, Virginia, United States
      • Watson Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; one placebo capsule orally, once daily, with food for up to 4 weeks
Active Comparator: silodsosin	Drug: silodosin; one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Spontaneous Stone Passage (Distal Stones)	Time to stone passage for distally-located stones is assessed by entries in subject diaries.	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Watson Pharmaceuticals
• Investigators: Study Director: Scott Olsen, MPH, Watson Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: kidney stones; ureteral stones; renal colic; ureteral calculi; medical expulsive therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urinary Calculi; Urolithiasis; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: SIL1001