Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) (CPCRN RCT#2)

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Conditions

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Treatments

Drug: Pregabalin

Drug: Placebo

Study type

Interventional

Funder types

NIH

Identifiers

NCT00371033

CPCRN2 Pregabalin

U01DK065209 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Primary Objectives

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
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.

Enrollment

324 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.