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

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

Detailed Description
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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.

Official Title
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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 Syndrome (CP/CPPS)

Conditions
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Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pregabalin | Drug: Pregabalin<br>* dosage<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |