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

Study of Silodosin to Facilitate Passage of Urinary Stones

Sponsors

Lead sponsor: Watson Pharmaceuticals

Source Watson Pharmaceuticals
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.

Overall Status Completed
Start Date June 2010
Completion Date July 2012
Primary Completion Date July 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. 4 weeks
Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. 4 weeks
Secondary Outcome
Measure Time Frame
Time to Spontaneous Stone Passage (Distal Stones) 4 weeks
Outpatient Narcotic Analgesic Use for Pain Relief 4 weeks
Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) 4 weeks
Time to Spontaneous Stone Passage (All Stones) 4 weeks
Enrollment 239
Condition
Intervention

Intervention type: Drug

Intervention name: silodosin

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

Arm group label: silodsosin

Intervention type: Drug

Intervention name: placebo

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

Arm group label: 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Scott Olsen, MPH Study Director Watson Pharmaceuticals, Inc.
Location
facility
Watson Investigational Site | Birmingham, Alabama, United States
Watson Investigational Site | Anchorage, Alaska, United States
Watson Investigative Site | Mission Hills, California, United States
Watson Investigational Site | Murrieta, California, United States
Watson Investigational Site | San Diego, California, United States
Watson Investigational Site | Daytona Beach, Florida, United States
Watson Investigational Site | Gainesville, Florida, United States
Watson Investigational Site | Orange City, Florida, United States
Watson Investigative Site | Overland Park, Kansas, United States
Watson Investigative Site | North Kansas City, Missouri, United States
Watson Investigational Site | 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 | 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 | Cincinnati, Ohio, United States
Watson Investigational Site | Columbus, Ohio, United States
Watson Investigational Site | Bala Cynwyd, Pennsylvania, United States
Watson Investigational Site | Lancaster, Pennsylvania, United States
Watson Investigational Site | Myrtle Beach, South Carolina, United States
Watson Investigational Site | Dallas, Texas, United States
Watson Investigational Site | San Antonio, Texas, United States
Watson Investigational Site | Virginia Beach, Virginia, United States
Location Countries

United States

Verification Date

July 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: silodsosin

Arm group type: Active Comparator

Arm group label: placebo

Arm group type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov