Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
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
1 other identifier
interventional
153
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
Shorter than P25 for phase_2
22 active sites
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
August 21, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
February 24, 2012
CompletedFebruary 24, 2012
January 1, 2012
1.1 years
August 21, 2008
January 23, 2012
January 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Study Arms (3)
Silodosin 4 mg
EXPERIMENTAL4 mg daily
Silodosin 8 mg
EXPERIMENTALSilodosin 8 mg daily
Placebo
PLACEBO COMPARATOR1 placebo capsule daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Watson Investigational Site
San Diego, California, United States
Watson Investigational Site
Denver, Colorado, United States
Watson Investigational Site
Columbus, Georgia, United States
Watson Investigational Site
Roswell, Georgia, United States
Watson Investigational Site
Jeffersonville, Indiana, United States
Watson Investigational Site
West Des Moines, Iowa, United States
Watson Investigational Site
Baltimore, Maryland, United States
Watson Investigational Site
Boston, Massachusetts, United States
Watson Investigational Site
Watertown, Massachusetts, United States
Watson Investigational Site
Omaha, Nebraska, United States
Watson Investigational Site
Voorhees Township, New Jersey, United States
Watson Investigational Site
Albuquerque, New Mexico, United States
Watson Investigational Site
Garden City, New York, United States
Watson Investigational Site
Kingston, New York, United States
Watson Investigational Site
New York, New York, United States
Watson Investigational Site
Poughkeepsie, New York, United States
Watson Investigational Site
Columbus, Ohio, United States
Watson Investigational Site
Bethany, Oklahoma, United States
Watson Investigational Site
Edmond, Oklahoma, United States
Watson Investigational Site
State College, Pennsylvania, United States
Watson Investigational Site
Mountlake Terrace, Washington, United States
Watson Investigational Site
Spokane, Washington, United States
Related Publications (1)
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.
PMID: 21571345DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
- Organization
- Watson Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Kim Caramelli, MS
Watson Pharmaceuticals
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
August 21, 2008
First Posted
August 25, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
February 24, 2012
Results First Posted
February 24, 2012
Record last verified: 2012-01