Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (… (NCT00371033) | Clinical Trial Compass
CompletedPhase 3
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
United States324 participantsStarted 2006-03
Plain-language summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 orch…
What they're measuring
1
Decrease in the NIH-CPSI Total Score by at Least 6 Points
Timeframe: Baseline and 6 weeks
Trial details
NCT IDNCT00371033
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)