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

Primary Purpose

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Charles R Drew University of Medicine & Science
  • David Geffen School of Medicine at UCLA
  • Stanford University Medical Center
  • Northwestern University Feinberg School of Medicine
  • University of Maryland
  • Harvard Medical School
  • University of Mississippi Medical Center
  • Cleveland Clinic Foundation
  • Temple University School of Medicine
  • University of Washington Harborview Medical Center
  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Pregabalin

Placebo

Outcomes

Primary Outcome Measures

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score

Secondary Outcome Measures

Subscales of the NIH-CPSI
Global Response Assessment
Hospital Anxiety & Depression Scale
McGill Pain Questionnaire
Medical Outcomes Study Short Form 12
Pain Medication Questionnaire
Sexual Health Inventory for Men
Symptom Assessment Form

Full Information

First Posted
August 31, 2006
Last Updated
March 15, 2011
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00371033
Brief Title
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Acronym
CPCRN RCT#2
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
318 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pregabalin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
dosage
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
dosage
Primary Outcome Measure Information:
Title
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Subscales of the NIH-CPSI
Time Frame
6 weeks
Title
Global Response Assessment
Time Frame
6 weeks
Title
Hospital Anxiety & Depression Scale
Time Frame
6 weeks
Title
McGill Pain Questionnaire
Time Frame
6 weeks
Title
Medical Outcomes Study Short Form 12
Time Frame
6 weeks
Title
Pain Medication Questionnaire
Time Frame
6 weeks
Title
Sexual Health Inventory for Men
Time Frame
6 weeks
Title
Symptom Assessment Form
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kusek, PhD
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lee Nyberg, PhD, MD
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
Facility Information:
Facility Name
Charles R Drew University of Medicine & Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5118
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Washington Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20876412
Citation
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.
Results Reference
derived

Learn more about this trial

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

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