Overview

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)

Summary

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
Arm
(Active Comparator)
Pregabalin
pregabalin
dosage
(Placebo Comparator)
Placebo
placebo
dosage

Primary Outcomes

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

Secondary Outcomes

Measure
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).