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Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740779
First received: August 21, 2008
Last updated: January 23, 2012
Last verified: January 2012
History of Changes

August 21, 2008
January 23, 2012
September 2008
October 2009   (final data collection date for primary outcome measure)
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
NIH-CPSI total score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00740779 on ClinicalTrials.gov Archive Site
Not Provided
  • NIH-CPSI pain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • NIH-CPSI urinary symptoms score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
  • Drug: Silodosin 8 mg
    Silodosin 8 mg daily
    Other Name: Rapaflo
  • Drug: Placebo
    Placebo
    Other Name: Placebo control.
  • Drug: Silodosin 4 mg
    Silodosin 4 mg daily
    Other Name: Rapaflo
  • Experimental: Silodosin 4 mg
    4 mg daily
    Intervention: Drug: Silodosin 4 mg
  • Experimental: Silodosin 8 mg
    Silodosin 8 mg daily
    Intervention: Drug: Silodosin 8 mg
  • Placebo Comparator: Placebo
    1 placebo capsule daily
    Intervention: Drug: Placebo
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. Epub 2011 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740779
SI08001
No
Watson Pharmaceuticals
Watson Pharmaceuticals
Not Provided
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
Watson Pharmaceuticals
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP