Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356720
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2006-07-25
Brief Title:
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 15 Versus Oral Azithromycin in Treatment of Trachoma
Sponsor:
Laboratoires Thea
Organization:
Laboratoires Thea
Study Overview
Official Title:
Clinical Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 15 Instilled Twice Daily for 2 or 3 Days Versus Oral Azithromycin in Treatment of Trachoma
Status:
COMPLETED
Status Verified Date:
2006-07
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:
To assess in children the efficacy and safety of 2 dosing regimens of T1225 15 eye drops in comparison to a reference product single-dose oral azithromycin AZM 20 mgkg for the treatment of active trachoma Evaluation of clinical efficacy was primary of clinical cure at Day 60 in Per Protocol Set microbiological evaluation was secondary
Detailed Description:
The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment T1225 15 eye drops BID for 3 days with a shorter duration of treatment T1225 15 eye drops BID for 2 days and with a single oral administration of AZM 20 mgkg in patients suffering from active trachoma The study was to be performed in approximately 600 children aged 1 to 10 years from Guinea Conakry and Pakistan
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