Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272409
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-09
Brief Title:
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children
Sponsor:
EMS
Organization:
EMS
Study Overview
Official Title:
Phase III Multicenter Double-blind Planned Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
SIERRA
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years
Detailed Description:
double-blind superiority parallel group trial
Experiment duration 05 days
03 visits days 0 5 and 28
Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
Adverse events evaluation
Experiment duration 05 days
03 visits days 0 5 and 28
Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
Adverse events evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None