Clinical Trial: An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Brief Summary: 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. We plan to study the use of CC-10004 in men with CP/CPPS.
Detailed Summary:
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.
Sponsor: Kenneth Peters, MD
Current Primary Outcome: 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.
Original Primary Outcome: To evaluate the efficacy of CC-10004 in patients with Chronic Prostatitis or Chronic Pelvic Pain Syndrome (CP/CPPS). [ Time Frame: 16 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: To evaluate the safety of CC-10004 in patients with CP/CPPS [ Time Frame: 16 weeks ]
Information By: William Beaumont Hospitals
Dates:
Date Received: June 18, 2008
Date Started: June 2008
Date Completion:
Last Updated: September 25, 2014
Last Verified: September 2014
