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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014