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

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Pregabalin

Criteria

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.