Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236990
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-10-07
Brief Title:
An Effectiveness and Safety Study of ELMIRON Pentosan Polysulfate Sodium for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Trial of ELMIRON Pentosan Polysulfate Sodium for the Treatment of Chronic Non-Bacterial Prostatitis
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None