Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.