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OpenTrials
Completed

NCT Number: NCT00740779

Use of Silodosin to Treat 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.

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Key information

Conditions

Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatitis Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Watson Investigational Site, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin 8 mg

Drug

Silodosin 8 mg daily

Other names: Rapaflo

Placebo

Drug

Placebo

Other names: Placebo control.

Silodosin 4 mg

Drug

Silodosin 4 mg daily

Other names: Rapaflo

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2008
Registry last updated
Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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