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

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00371033

Purpose

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

Condition	Intervention	Phase
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)	Drug: Pregabalin Drug: Placebo	Phase III

MedlinePlus related topics: Pelvic Pain

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subscales of the NIH-CPSI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Global Response Assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety & Depression Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
McGill Pain Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study Short Form 12 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Pain Medication Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Sexual Health Inventory for Men [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Symptom Assessment Form [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	318
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pregabalin	Drug: Pregabalin dosage
2: Placebo Comparator Placebo	Drug: Placebo dosage

Detailed Description:

Primary Objectives

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
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371033

Locations

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

Sponsors and Collaborators

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)

More Information

No publications provided

Responsible Party:	NIH ( LeRoy Nyberg, MD )
Study ID Numbers:	DK65209-CPCRN-2
Study First Received:	August 31, 2006
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00371033 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Pregabalin
Pain
Genital Diseases, Male
Prostatitis
Signs and Symptoms
Pelvic Pain

Mental Disorders
Chronic Disease
Analgesics
Peripheral Nervous System Agents
Somatoform Disorders
Anticonvulsants

Additional relevant MeSH terms:

Disease Attributes
Disease
Prostatic Diseases
Physiological Effects of Drugs
Pregabalin
Pain
Genital Diseases, Male
Pharmacologic Actions
Prostatitis
Signs and Symptoms
Pelvic Pain

Pathologic Processes
Sensory System Agents
Mental Disorders
Therapeutic Uses
Syndrome
Chronic Disease
Peripheral Nervous System Agents
Analgesics
Somatoform Disorders
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009