Clinical trial NCT00371033: Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-09-01
Enrollment: 318
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Subscales of the NIH-CPSI
timeFrame: 6 weeks
measure: Global Response Assessment
timeFrame: 6 weeks
measure: Hospital Anxiety & Depression Scale
timeFrame: 6 weeks
measure: McGill Pain Questionnaire
timeFrame: 6 weeks
measure: Medical Outcomes Study Short Form 12
timeFrame: 6 weeks
measure: Pain Medication Questionnaire
timeFrame: 6 weeks
measure: Sexual Health Inventory for Men
timeFrame: 6 weeks
measure: Symptom Assessment Form
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R Drew University of Medicine & Science
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: John Kusek, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Lee Nyberg, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Pontari MA, Krieger JN, Litwin MS, White PC, Anderson RU, McNaughton-Collins M, Nickel JC, Shoskes DA, Alexander RB, O'Leary M, Zeitlin S, Chuai S, Landis JR, Cen L, Propert KJ, Kusek JW, Nyberg LM Jr, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network-2. Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1586-93. doi: 10.1001/archinternmed.2010.319.