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

Phase 3

• Conditions: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
• Interventions: Drug: Placebo; Drug: Pregabalin

• 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-01
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-15
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 318

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Pregabalin	Pregabalin

Primary Outcome Measures

Name	Time	Method
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score	6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Charles R Drew University of Medicine & Science; 🇺🇸 Los Angeles, California, United States

Queen's University; 🇨🇦 Kingston, Ontario, Canada

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Harvard Medical School; 🇺🇸 Boston, Massachusetts, 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