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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00371033 |
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Condition | Intervention | Phase |
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Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) |
Drug: Pregabalin Drug: Placebo |
Phase III |
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) |
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 |
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1: Active Comparator
Pregabalin
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Drug: Pregabalin
dosage
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2: Placebo Comparator
Placebo
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Drug: Placebo
dosage
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Primary Objectives
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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) |
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 |
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 |
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 |