Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01406587
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2011-07-26
Brief Title:
Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
Sponsor:
Pinnacle Pharmaceuticals Inc
Organization:
Pinnacle Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Parallel Group Evaluation of the Efficacy and Safety of 50 mg 100 mg and 200 mg PP4001 Twice Daily for the Treatment of Burning During Urination Pain and Urination Frequency Associated With Uncomplicated Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2011-10
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:
PP4001 is a medication not yet approved by the US FDA This is a phase 2 multi-center randomized double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection After the screening patients are randomized to receive one of three doses of PP4001 or placebo Patients are screened and randomized on the same day and take 4 doses of study drug one dose every 12 hours Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period The primary endpoint is burning during urination
Detailed Description:
None
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