Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
CompletedPhase 3NCT00371033
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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)
- Interventions
- 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00371033