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

January 23, 2012 updated by: Watson Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • Watson Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Watson Investigational Site
    • Georgia
      • Columbus, Georgia, United States
        • Watson Investigational Site
      • Roswell, Georgia, United States
        • Watson Investigational Site
    • Indiana
      • Jeffersonville, Indiana, United States
        • Watson Investigational Site
    • Iowa
      • West Des Moines, Iowa, United States
        • Watson Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • Watson Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Watson Investigational Site
      • Watertown, Massachusetts, United States
        • Watson Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Watson Investigational Site
    • New Jersey
      • Voorhees, New Jersey, United States
        • Watson Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Watson Investigational Site
    • New York
      • 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
    • Ohio
      • Columbus, Ohio, United States
        • Watson Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States
        • Watson Investigational Site
      • Edmond, Oklahoma, United States
        • Watson Investigational Site
    • Pennsylvania
      • State College, Pennsylvania, United States
        • Watson Investigational Site
    • Washington
      • Mountlake Terrace, Washington, United States
        • Watson Investigational Site
      • Spokane, Washington, United States
        • Watson Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silodosin 4 mg
4 mg daily
Drug: Silodosin 4 mg
Silodosin 4 mg daily
Other Names:
  • Rapaflo
Experimental: Silodosin 8 mg
Silodosin 8 mg daily
Drug: Silodosin 8 mg
Silodosin 8 mg daily
Other Names:
  • Rapaflo
Placebo Comparator: Placebo
1 placebo capsule daily
Drug: Placebo
Placebo
Other Names:
  • Placebo control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Kim Caramelli, MS, Watson Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI08001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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