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

Phase 3

Completed

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

Interventions: Drug: Pregabalin
Drug: Placebo

Registration Number: NCT00371033

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 324

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Decrease in the NIH-CPSI Total Score by at Least 6 Points	Baseline and 6 weeks	Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.

Secondary Outcome Measures

Name	Time	Method
Subscales of the NIH-CPSI	6 weeks	The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
Moderately or Markedly Improve on Global Response Assessment (GRA)	6 weeks	The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.
Hospital Anxiety & Depression Scale	6 weeks	Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)
McGill Pain Questionnaire	6 weeks	The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain.
Medical Outcomes Study Short Form 12	6 weeks	Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical \[PCS\] and Mental \[MCS\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life)
Sexual Health Inventory for Men	6 weeks	Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)

Trial Locations

Locations (11): Charles R Drew University of Medicine & Science
🇺🇸
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
🇺🇸
Los Angeles, California, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Northwestern University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Harvard Medical School
🇺🇸
Boston, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Temple University School of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
University of Washington Harborview Medical Center
🇺🇸
Seattle, Washington, United States
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Charles R Drew University of Medicine & Science
🇺🇸Los Angeles, California, United States