The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
324
Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks.
Placebo at same frequency as pregabablin
Charles R Drew University of Medicine & Science
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Decrease in the NIH-CPSI Total Score by at Least 6 Points
Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
Time frame: Baseline and 6 weeks
Subscales of the NIH-CPSI
The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
Time frame: 6 weeks
Moderately or Markedly Improve on Global Response Assessment (GRA)
The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.
Time frame: 6 weeks
Hospital Anxiety & Depression Scale
Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)
Time frame: 6 weeks
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Harvard Medical School
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
...and 1 more locations
McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain.
Time frame: 6 weeks
Medical Outcomes Study Short Form 12
Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical \[PCS\] and Mental \[MCS\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life)
Time frame: 6 weeks
Sexual Health Inventory for Men
Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)
Time frame: 6 weeks