Clinical Trial: Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain

Brief Summary: The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Detailed Summary:

Primary Objectives

  1. To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI
  2. To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS participants

Design

Eligible participants will receive either pregabalin or placebo, randomly assigned at a ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to take the study medication 3 times per day. There are 3 clinic visits and 2 telephone contacts. Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks. For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts.


Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score [ Time Frame: 6 weeks ]

Original Primary Outcome: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score

Current Secondary Outcome:

  • Subscales of the NIH-CPSI [ Time Frame: 6 weeks ]
  • Global Response Assessment [ Time Frame: 6 weeks ]
  • Hospital Anxiety & Depression Scale [ Time Frame: 6 weeks ]
  • McGill Pain Questionnaire [ Time Frame: 6 weeks ]
  • Medical Outcomes Study Short Form 12 [ Time Frame: 6 weeks ]
  • Pain Medication Questionnaire [ Time Frame: 6 weeks ]
  • Sexual Health Inventory for Men [ Time Frame: 6 weeks ]
  • Symptom Assessment Form [ Time Frame: 6 weeks ]


Original Secondary Outcome:

  • Subscales of the NIH-CPSI
  • Global Response Assessment
  • Hospital Anxiety & Depression Scale
  • McGill Pain Questionnaire
  • Medical Outcomes Study Short Form 12
  • Pain Medication Questionnaire
  • Sexual Health Inventory for Men
  • Symptom Assessment Form


Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dates:
Date Received: August 31, 2006
Date Started: March 2006
Date Completion: April 2008
Last Updated: March 15, 2011
Last Verified: March 2011