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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain
Drug Information available for: Silodosin
U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Enrollment: 153
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740779

  Show 22 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
  More Information

No publications provided by Watson Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00740779     History of Changes
Other Study ID Numbers: SI08001
Study First Received: August 21, 2008
Results First Received: January 23, 2012
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
prostatitis, chronic pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Chronic Disease
Somatoform Disorders
Pain
Signs and Symptoms
 Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013