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

Last updated: March 15, 2011
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Trial Status Unknown

Phase

3

Condition

Urinary Tract Infections

Soft Tissue Infections

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT00371033
DK65209-CPCRN-2 (IND)
  • Ages > 18
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 atleast a three (3) month period within the last six (6) months.

Exclusion

Exclusion Criteria:

  • Participant has continued evidence of facultative Gram negative or enterococcus with avalue of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated byrepeat 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 andpioglitazone).

  • 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 ulcerativecolitis, 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 hisunderstanding of consent and his ability to comply with the protocol.

Study Design

Total Participants: 318
Study Start date:
March 01, 2006
Estimated Completion Date:
April 30, 2008

Study 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.

Connect with a study center

  • Queen's University

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Charles R Drew University of Medicine & Science

    Los Angeles, California 90059
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095-1738
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305-5118
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Harvard Medical School

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Temple University School of Medicine

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Washington Harborview Medical Center

    Seattle, Washington 98108
    United States

    Site Not Available

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