Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01478620
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2011-11-21
Brief Title:
Safety and Efficacy of Canephron N in the Management of Uncomplicated Urinary Tract Infections uUTI
Sponsor:
Bionorica SE
Organization:
Bionorica SE
Study Overview
Official Title:
An Open-label Non-randomized Multicenter Interventional Study to Investigate the Safety and Efficacy of Canephron N in the Management of Uncomplicated Urinary Tract Infections uUTI
Status:
COMPLETED
Status Verified Date:
2019-02
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 objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron N in the management strategy of uncomplicated lower urinary tract infections UTIs
Detailed Description:
250 patients total 7-day treatment period with Canephron N 2 tablets three times a day and a follow-up period until Day 37 A total of three visits are planned on Day 0 screening start of study treatment Day 7 end of study treatment and Day 37 end of study visit
Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time In this case Canephron N intake will be stopped
At least 50 of the patients ie 125 subjects should have received a 7-day treatment with Canephron N If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached
Due to withdrawal of study in Russia total study population was reduced to 125 patients
Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time In this case Canephron N intake will be stopped
At least 50 of the patients ie 125 subjects should have received a 7-day treatment with Canephron N If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached
Due to withdrawal of study in Russia total study population was reduced to 125 patients
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 |
|---|---|---|---|
| 2011-000838-11 | EUDRACT_NUMBER | None | None |