NCT00236990

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

First QC Date

October 7, 2005

Last Update Submit

June 30, 2011

Conditions

Prostatitis

Keywords

prostatitisElmironpentosan polysulfate sodium

Outcome Measures

Primary Outcomes (1)

  • The change in total NIH-CPSI score from baseline to Week 12

Secondary Outcomes (1)

  • 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.

Study Arms (1)

001

EXPERIMENTAL

pentosan polysulfate sodium

Drug: pentosan polysulfate sodium

Interventions

pentosan polysulfate sodiumDRUG
001

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatitis

Interventions

Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfuric AcidsSulfur AcidsSulfur CompoundsOrganic ChemicalsPolysaccharidesCarbohydrates

Study Officials

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Completion

September 1, 2005

Last Updated

July 1, 2011

Record last verified: 2011-06