Prostatitis
Conditions
Keywords
prostatitis, Elmiron, pentosan polysulfate sodium
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of ELMIRON® in the treatment of chronic non-bacterial inflammation of the prostate gland.
Detailed description
The objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. Safety evaluations will be assessed throughout the study. The hypothesis of the study is that ELMIRON® will be more effective than placebo, as based on the change in the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.
Interventions
Sponsors
Alza Corporation, DE, USA
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome * symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause * symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months.
Exclusion criteria
* Clinically significant medical problems or other organ abnormalities * psychiatric disorders * urinary tract infection during the last three months * history of bladder, urethral or prostate cancer * Prostate Specific Antigen (PSA) greater than or equal to 4 ng/mL * diagnosis or treatment for genital herpes or herpes flare within the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in total NIH-CPSI score from baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant-reported Global Response Assessment at Week 12. Brief Male Sexual Function Index at Weeks 4, 8, and 12. Pelvic Pain Urgency and Frequency symptom scale at Weeks 4, 8, and 12. | — |
Outcome results
None listed