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

CompletedPhase 3NCT00371033
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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

Study details

Official title
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
  • Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date
2006-03
Primary completion
2008-01
Sex
Male
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Canada, United States
Total sites listed
11

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Canadian sites (1)

FacilityCityProvince
Queen's UniversityKingstonOntario

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00371033