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
- 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
- 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