Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- Conditions
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00371033
- Brief Summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 318
- Participant has signed and dated the appropriate Informed Consent document.
- Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
- Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.
- Participant has a calculated creatinine clearance of <60 mL/min.
- Participant has a platelet count <100,000/mm3.
- Participant is allergic to antiepileptic/antiseizure medications.
- Participant has a known allergy or sensitivity to pregabalin (Lyrica®).
- Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).
- Participant has New York Heart Association Class III or IV congestive heart failure.
- Participant has a history of thrombocytopenia, or a bleeding diathesis.
- Participant has a history of prostate, bladder or urethral cancer.
- Participant has a history of alcohol abuse.
- Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
- Participant has undergone pelvic radiation or systemic chemotherapy.
- Participant has undergone intravesical chemotherapy.
- Participant has been treated with intravesical BCG.
- Participant has unilateral orchalgia without other pelvic symptoms.
- Participant has an active urethral stricture.
- Participant has a neurological disease or disorder affecting the bladder.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo 1 Pregabalin Pregabalin
- Primary Outcome Measures
Name Time Method National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score 6 weeks
- Secondary Outcome Measures
Name Time Method Subscales of the NIH-CPSI 6 weeks Global Response Assessment 6 weeks Hospital Anxiety & Depression Scale 6 weeks McGill Pain Questionnaire 6 weeks Medical Outcomes Study Short Form 12 6 weeks Pain Medication Questionnaire 6 weeks Sexual Health Inventory for Men 6 weeks Symptom Assessment Form 6 weeks
Trial Locations
- Locations (11)
Charles R Drew University of Medicine & Science
🇺🇸Los Angeles, California, United States
Queen's University
🇨🇦Kingston, Ontario, Canada
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Harvard Medical School
🇺🇸Boston, Massachusetts, 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