Study of Silodosin to Facilitate Passage of Urinary Stones

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144949
• Other study ID #: SIL1001
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2010
• Last updated: July 21, 2014
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2014
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urinary Calculi
• Urolithiasis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Time to Spontaneous Stone Passage (Distal Stones)	Time to stone passage for distally-located stones is assessed by entries in subject diaries.	4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No