Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457353
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2007-04-05
Brief Title:
ENterogermina Bacillus Clausii In the manaGeMent of diarrheA in Children
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy ORT in Combination With Spores of Bacillus Clausii EnterogerminaVersus ORT Alone Administered for 5 Days With the Treatment of Acute Diarrhea in Children
Status:
COMPLETED
Status Verified Date:
2009-01
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:
ENIGMA
Brief Summary:
Primary
To demonstrate the efficacy of Enterogermina in reducing the duration of acute diarrhea in children
Secondary
To evaluate the safety of Enterogermina in acute diarrhea in Indian children
To demonstrate the efficacy of Enterogermina in reducing the duration of acute diarrhea in children
Secondary
To evaluate the safety of Enterogermina in acute diarrhea in Indian children
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