An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
|ClinicalTrials.gov Identifier: NCT00701311|
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : May 16, 2014
Last Update Posted : October 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome||Drug: CC-10004||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
Experimental: Study Drug CC-10004
Study drug CC-10004 20mg taken orally twice a day.
CC-10004 20 mg per day
- Global Response Assessment [ Time Frame: 12 weeks ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701311
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, MD||William Beaumont Hospitals|