An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome|
- Global Response Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.
The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
|Study Start Date:||June 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Study Drug CC-10004
Study drug CC-10004 20mg taken orally twice a day.
CC-10004 20 mg per day
Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life.
Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. Unlike bacterial prostatitis, where a clear infecting organism can be determined, CP/CPPS is not always treated with antibiotics.
Due to the significant inflammatory nature of CP/CPPS, most prior therapies have focused on targeting the inflammation. CC-10004 in several studies has shown to be an inhibitor of inflammatory mediators, and may decrease the pain experienced from CP/CPPS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701311
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, MD||William Beaumont Hospitals|