Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402688
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2006-11-21
Brief Title:
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Double-Blind Phase 3B Study to Compare the Safety and Clinical Efficacy of Levofloxacin in 750mg for 2 Weeks and Levofloxacin 750mg for 3 Weeks to That of Levofloxacin 500mg for 4 Weeks in the Treatment of Chronic Prostatitis
Status:
COMPLETED
Status Verified Date:
2013-09
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 compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis
Detailed Description:
The optimal duration of treatment for chronic prostatitis remains unclear Historically therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication Levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks This multicenter double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage randomized patients are assigned different treatments based on chance study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis Safety analyses will involve the examination of the incidence severity and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests Patients will receive one of the following three dosing options levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks or levofloxacin 500 mg orally once-a-day for 4 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CR012103 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |