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

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

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00371033
• Other study ID #: DK65209-CPCRN-2 (IND)
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 31, 2006
• Last updated: March 15, 2011
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 318
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Pregabalin
dosage
• Placebo
dosage

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario
United States	University of Maryland	Baltimore	Maryland
United States	Harvard Medical School	Boston	Massachusetts
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Charles R Drew University of Medicine & Science	Los Angeles	California
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	University of Washington Harborview Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score		6 weeks	No
Secondary	Subscales of the NIH-CPSI		6 weeks	No
Secondary	Global Response Assessment		6 weeks	No
Secondary	Hospital Anxiety & Depression Scale		6 weeks	No
Secondary	McGill Pain Questionnaire		6 weeks	No
Secondary	Medical Outcomes Study Short Form 12		6 weeks	No
Secondary	Pain Medication Questionnaire		6 weeks	No
Secondary	Sexual Health Inventory for Men		6 weeks	No
Secondary	Symptom Assessment Form		6 weeks	No