Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Primary Purpose
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Silodosin 8 mg
Placebo
Silodosin 4 mg
Sponsored by
About this trial
This is an interventional treatment trial for Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome focused on measuring prostatitis, chronic pelvic pain
Eligibility Criteria
Inclusion Criteria:
- Male, at least 18 years of age
- Has a total NIH-CPSI total score of 15
- Has a NIH-CPSI pain score of 8
- Has had pain in the pelvic region for at least 3 months prior to screening
Exclusion Criteria:
- Has previously participated in a Watson study with silodosin
- Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
- Has experience ≥2 urinary tract infections within the previous 12 months
- Has any medical condition that in the opinion of the investigator precludes safe participation in the study
- Has any medical condition that could confound the efficacy evaluation
- Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
- Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
- Has participated in a study involving the administration of an investigational agent within the past 30 days
Sites / Locations
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
- Watson Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Silodosin 4 mg
Silodosin 8 mg
Placebo
Arm Description
4 mg daily
Silodosin 8 mg daily
1 placebo capsule daily
Outcomes
Primary Outcome Measures
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT00740779
First Posted
August 21, 2008
Last Updated
January 23, 2012
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00740779
Brief Title
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Official Title
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
Detailed Description
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Keywords
prostatitis, chronic pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silodosin 4 mg
Arm Type
Experimental
Arm Description
4 mg daily
Arm Title
Silodosin 8 mg
Arm Type
Experimental
Arm Description
Silodosin 8 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo capsule daily
Intervention Type
Drug
Intervention Name(s)
Silodosin 8 mg
Other Intervention Name(s)
Rapaflo
Intervention Description
Silodosin 8 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control.
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Silodosin 4 mg
Other Intervention Name(s)
Rapaflo
Intervention Description
Silodosin 4 mg daily
Primary Outcome Measure Information:
Title
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Description
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male, at least 18 years of age
Has a total NIH-CPSI total score of 15
Has a NIH-CPSI pain score of 8
Has had pain in the pelvic region for at least 3 months prior to screening
Exclusion Criteria:
Has previously participated in a Watson study with silodosin
Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
Has experience ≥2 urinary tract infections within the previous 12 months
Has any medical condition that in the opinion of the investigator precludes safe participation in the study
Has any medical condition that could confound the efficacy evaluation
Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
Has participated in a study involving the administration of an investigational agent within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Caramelli, MS
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Watson Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Watson Investigational Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Watson Investigational Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Watson Investigational Site
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Watson Investigational Site
City
West Des Moines
State/Province
Iowa
Country
United States
Facility Name
Watson Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Watson Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Watson Investigational Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Watson Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Watson Investigational Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Watson Investigational Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Kingston
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Watson Investigational Site
City
Bethany
State/Province
Oklahoma
Country
United States
Facility Name
Watson Investigational Site
City
Edmond
State/Province
Oklahoma
Country
United States
Facility Name
Watson Investigational Site
City
State College
State/Province
Pennsylvania
Country
United States
Facility Name
Watson Investigational Site
City
Mountlake Terrace
State/Province
Washington
Country
United States
Facility Name
Watson Investigational Site
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21571345
Citation
Nickel JC, O'Leary MP, Lepor H, Caramelli KE, Thomas H, Hill LA, Hoel GE. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14.
Results Reference
derived
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Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
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