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

Completed · Phase 3 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT00371033

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

324

Starts

2006-03-01

Expected to finish

2008-04-30

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• Queen's University — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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