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

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ClinicalTrials.gov Identifier: NCT00371033
Recruitment Status : Unknown
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2006
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Drug: Pregabalin Drug: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : March 2006
Primary Completion Date : January 2008
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain
Drug Information available for: Pregabalin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Pregabalin
Drug: Pregabalin
dosage
Placebo Comparator: 2
Placebo
Drug: Placebo
dosage


Outcome Measures

Primary Outcome Measures :
  1. National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Subscales of the NIH-CPSI [ Time Frame: 6 weeks ]
  2. Global Response Assessment [ Time Frame: 6 weeks ]
  3. Hospital Anxiety & Depression Scale [ Time Frame: 6 weeks ]
  4. McGill Pain Questionnaire [ Time Frame: 6 weeks ]
  5. Medical Outcomes Study Short Form 12 [ Time Frame: 6 weeks ]
  6. Pain Medication Questionnaire [ Time Frame: 6 weeks ]
  7. Sexual Health Inventory for Men [ Time Frame: 6 weeks ]
  8. Symptom Assessment Form [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371033


Locations
United States, California
Charles R Drew University of Medicine & Science
Los Angeles, California, United States, 90059
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1738
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
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

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)
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Prostatitis
Chronic Disease
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs