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

NCT00371033 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CPCRN2 PregabalinU01DK065209
• Study Type: interventional
• Target: 324
• Locations: 2 countries
• Sites: 11

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Decrease in the NIH-CPSI Total Score by at Least 6 Points

  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.

  Baseline and 6 weeks

Secondary Outcomes (6)

• Subscales of the NIH-CPSI

  6 weeks

• Moderately or Markedly Improve on Global Response Assessment (GRA)

  6 weeks

• Hospital Anxiety & Depression Scale

  6 weeks

• McGill Pain Questionnaire

  6 weeks

• Medical Outcomes Study Short Form 12

  6 weeks

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin 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.

Pregabalin

Placebo DRUG

Placebo at same frequency as pregabablin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (11)

Charles R Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-1738, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5118, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98108, United States

Location

Queen's University

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 20876412 DERIVED

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: J. Richard Landis, PhD
• Organization: University of Pennsylvania

hultman@upenn.edu

215-573-4922

Study Officials

• John Kusek, PhD

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

  STUDY DIRECTOR

• Lee Nyberg, PhD, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 1, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: April 30, 2008
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (10); CA (1)