NCT00793819

Brief Summary

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 9, 2012

Completed
Last Updated

March 9, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

November 17, 2008

Results QC Date

February 7, 2012

Last Update Submit

February 7, 2012

Conditions

NocturiaProstatic Hyperplasia

Keywords

nocturiaBPHbenign prostate hyperplasianocturia in men with benign prostate hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Change in Nocturia Episodes

    12 weeks

Study Arms (2)

1 Silodosin

EXPERIMENTAL
Drug: silodosin

2 Placebo

PLACEBO COMPARATOR
Drug: silodosin

Interventions

silodosinDRUG

α1-adrenergic antagonist

Also known as: Rapaflo
1 Silodosin2 Placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (\>=2 episodes per night)

You may not qualify if:

  • Medical conditions that would confound the efficacy evaluation.
  • Medical conditions in which it would be unsafe to use an alpha-blocker.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with this alpha-blocker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Watson Investigational Site

Huntsville, Alabama, United States

Location

Watson Investigational Site

Laguna Hills, California, United States

Location

Watson Investigational Site

San Diego, California, United States

Location

Watson Investigational Site

Aventura, Florida, United States

Location

Watson Investigational Site

Clearwater, Florida, United States

Location

Watson Investigational Site

Orlando, Florida, United States

Location

Watson Investigational Site

Marietta, Georgia, United States

Location

Watson Investigational Site

Sandy Springs, Georgia, United States

Location

Watson Investigational Site

Coeur d'Alene, Idaho, United States

Location

Watson Investigational Site

West Des Moines, Iowa, United States

Location

Watson Investigational Site

Paducah, Kentucky, United States

Location

Watson Investigational Site

Greenbelt, Maryland, United States

Location

Watson Investigational Site

Troy, Michigan, United States

Location

Watson Investigational Site

Missoula, Montana, United States

Location

Watson Investigational Site

Omaha, Nebraska, United States

Location

Watson Investigational Site

Las Vegas, Nevada, United States

Location

Watson Investigational Site

Lawrenceville, New Jersey, United States

Location

Watson Investigational Site

Albuquerque, New Mexico, United States

Location

Watson Investigational Site

Bay Shore, New York, United States

Location

Watson Investigational Site

New York, New York, United States

Location

Watson Investigational Site

Williamsville, New York, United States

Location

Watson Investigational Site

Concord, North Carolina, United States

Location

Watson Investigational Site

Salisbury, North Carolina, United States

Location

Watson Investigational Site

Bethany, Oklahoma, United States

Location

Watson Investigational Site

Bala-Cynwyd, Pennsylvania, United States

Location

Watson Investigational Site

Myrtle Beach, South Carolina, United States

Location

Watson Investigational Site

Burien, Washington, United States

Location

MeSH Terms

Conditions

NocturiaProstatic Hyperplasia

Interventions

silodosin

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization
Watson Pharmaceuticals
gary.hoel@watson.com
801-588-6641

Study Officials

  • Kim Caramelli, MS

    Watson Pharmaceuticals

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 9, 2012

Results First Posted

March 9, 2012

Record last verified: 2012-02

Locations

US(27)