NCT01144949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 11, 2014

Completed
Last Updated

August 11, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

June 14, 2010

Results QC Date

February 7, 2014

Last Update Submit

July 21, 2014

Conditions

Ureteral CalculiKidney StonesUrolithiasis

Keywords

ureteral calculirenal colicureteral stoneskidney stonesmedical expulsive therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

silodsosin

ACTIVE COMPARATOR
Drug: silodosin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

silodosinDRUG

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

silodsosin
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Watson Investigational Site

Birmingham, Alabama, United States

Location

Watson Investigational Site

Anchorage, Alaska, United States

Location

Watson Investigative Site

Mission Hills, California, United States

Location

Watson Investigational Site

Murrieta, California, United States

Location

Watson Investigational Site

San Diego, California, United States

Location

Watson Investigational Site

Daytona Beach, Florida, United States

Location

Watson Investigational Site

Gainesville, Florida, United States

Location

Watson Investigational Site

Orange City, Florida, United States

Location

Watson Investigative Site

Overland Park, Kansas, United States

Location

Watson Investigative Site

North Kansas City, Missouri, United States

Location

Watson Investigational Site

Hackensack, New Jersey, United States

Location

Watson Investigational Site

Mount Laurel, New Jersey, United States

Location

Watson Investigational Site

Sewell, New Jersey, United States

Location

Watson Investigational Site

Voorhees Township, New Jersey, United States

Location

Watson Investigational Site

Albany, New York, United States

Location

Watson Investigational Site

Garden City, New York, United States

Location

Watson Investigational Site

New York, New York, United States

Location

Watson Investigational Site

Plainview, New York, United States

Location

Watson Investigational Site

Syracuse, New York, United States

Location

Watson Investigational Site

Cincinnati, Ohio, United States

Location

Watson Investigational Site

Columbus, Ohio, United States

Location

Watson Investigational Site

Bala-Cynwyd, Pennsylvania, United States

Location

Watson Investigational Site

Lancaster, Pennsylvania, United States

Location

Watson Investigational Site

Myrtle Beach, South Carolina, United States

Location

Watson Investigational Site

Dallas, Texas, United States

Location

Watson Investigational Site

San Antonio, Texas, United States

Location

Watson Investigational Site

Virginia Beach, Virginia, United States

Location

MeSH Terms

Conditions

Ureteral CalculiKidney CalculiUrolithiasisRenal Colic

Interventions

silodosin

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNephrolithiasisKidney DiseasesPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Gary Hoel, RPh PhD, VP Global Brands Clinical Research
Organization
Watson Laboratories, Inc.
gary.hoel@watson.com
801 588-6641

Study Officials

  • Scott Olsen, MPH

    Watson Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 16, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 11, 2014

Results First Posted

August 11, 2014

Record last verified: 2014-07

Locations

US(27)