This trial is active, not recruiting.

Condition chronic prostatitis/chronic pelvic pain syndrome (cp/cpps)
Treatments pregabalin, placebo
Phase phase 3
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2006
End date January 2008
Trial size 318 participants
Trial identifier NCT00371033, DK65209-CPCRN-2 (IND)


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
(Placebo Comparator)

Primary Outcomes

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
time frame: 6 weeks

Secondary Outcomes

Subscales of the NIH-CPSI
time frame: 6 weeks
Global Response Assessment
time frame: 6 weeks
Hospital Anxiety & Depression Scale
time frame: 6 weeks
McGill Pain Questionnaire
time frame: 6 weeks
Medical Outcomes Study Short Form 12
time frame: 6 weeks
Pain Medication Questionnaire
time frame: 6 weeks
Sexual Health Inventory for Men
time frame: 6 weeks
Symptom Assessment Form
time frame: 6 weeks

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

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)
Description Primary Objectives 1. To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI 2. To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS participants Design Eligible participants will receive either pregabalin or placebo, randomly assigned at a ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to take the study medication 3 times per day. There are 3 clinic visits and 2 telephone contacts. Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks. For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).