Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) (CPCRN RCT#2)

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)

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

Study Overview

• Status: Unknown
• Conditions: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
• Intervention / Treatment: Drug: Pregabalin; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 318
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Queen's University
• United States
  • California
    • Los Angeles, California, United States, 90059
      • Charles R Drew University of Medicine & Science
    • Los Angeles, California, United States, 90095-1738
      • David Geffen School of Medicine at UCLA
    • Stanford, California, United States, 94305-5118
      • Stanford University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine
  • Washington
    • Seattle, Washington, United States, 98108
      • University of Washington Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; dosage
Active Comparator: 1; Pregabalin	Drug: Pregabalin; dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Director: 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)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Anticipated): April 1, 2008

Study Registration Dates

• First Submitted: August 31, 2006
• First Submitted That Met QC Criteria: August 31, 2006
• First Posted (Estimate): September 1, 2006

Study Record Updates

• Last Update Posted (Estimate): March 16, 2011
• Last Update Submitted That Met QC Criteria: March 15, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Disease; Prostatic Diseases; Syndrome; Chronic Disease; Somatoform Disorders; Pelvic Pain; Prostatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: DK65209-CPCRN-2 (IND)