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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00371033
First received: August 31, 2006
Last updated: March 15, 2011
Last verified: March 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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
Active Comparator: 1
Pregabalin
Drug: Pregabalin
dosage
Placebo Comparator: 2
Placebo
Drug: Placebo
dosage

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
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
Stanford University Medical Center
Stanford, California, United States, 94305-5118
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
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 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LeRoy Nyberg, MD, NIH
ClinicalTrials.gov Identifier: NCT00371033     History of Changes
Other Study ID Numbers: DK65209-CPCRN-2 (IND)
Study First Received: August 31, 2006
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pelvic Pain
Pain
Central Nervous System Agents
Prostatitis
Chronic Disease
Somatoform Disorders
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014