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

NCT ID: NCT00371033

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo at same frequency as pregabablin

Interventions

Pregabalin

Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks.

Intervention Type: DRUG

Placebo

Placebo at same frequency as pregabablin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kusek, PhD

Role: STUDY_DIRECTOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lee Nyberg, PhD, MD

Role: STUDY_DIRECTOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Locations

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

Queen's University

Kingston, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 20876412 (View on PubMed)

Other Identifiers

U01DK065209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CPCRN2 Pregabalin

Identifier Type: -

Identifier Source: org_study_id