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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00740779
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome Drug: Silodosin 8 mg Drug: Placebo Drug: Silodosin 4 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain
Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: Silodosin 4 mg
4 mg daily
Drug: Silodosin 4 mg
Silodosin 4 mg daily
Other Name: Rapaflo

Experimental: Silodosin 8 mg
Silodosin 8 mg daily
Drug: Silodosin 8 mg
Silodosin 8 mg daily
Other Name: Rapaflo

Placebo Comparator: Placebo
1 placebo capsule daily
Drug: Placebo
Placebo
Other Name: Placebo control.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740779


Locations
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United States, California
Watson Investigational Site
San Diego, California, United States
United States, Colorado
Watson Investigational Site
Denver, Colorado, United States
United States, Georgia
Watson Investigational Site
Columbus, Georgia, United States
Watson Investigational Site
Roswell, Georgia, United States
United States, Indiana
Watson Investigational Site
Jeffersonville, Indiana, United States
United States, Iowa
Watson Investigational Site
West Des Moines, Iowa, United States
United States, Maryland
Watson Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
Watson Investigational Site
Boston, Massachusetts, United States
Watson Investigational Site
Watertown, Massachusetts, United States
United States, Nebraska
Watson Investigational Site
Omaha, Nebraska, United States
United States, New Jersey
Watson Investigational Site
Voorhees, New Jersey, United States
United States, New Mexico
Watson Investigational Site
Albuquerque, New Mexico, United States
United States, New York
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
United States, Ohio
Watson Investigational Site
Columbus, Ohio, United States
United States, Oklahoma
Watson Investigational Site
Bethany, Oklahoma, United States
Watson Investigational Site
Edmond, Oklahoma, United States
United States, Pennsylvania
Watson Investigational Site
State College, Pennsylvania, United States
United States, Washington
Watson Investigational Site
Mountlake Terrace, Washington, United States
Watson Investigational Site
Spokane, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Kim Caramelli, MS Watson Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740779    
Other Study ID Numbers: SI08001
First Posted: August 25, 2008    Key Record Dates
Results First Posted: February 24, 2012
Last Update Posted: February 24, 2012
Last Verified: January 2012
Keywords provided by Watson Pharmaceuticals:
prostatitis, chronic pelvic pain
Additional relevant MeSH terms:
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Prostatitis
Syndrome
Pelvic Pain
Chronic Disease
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Prostatic Diseases
Disease Attributes
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents