Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244148
Status:
TERMINATED
Last Update Posted:
2023-01-13
First Post:
2022-01-03
Brief Title:
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
Sponsor:
Church Dwight Company Inc
Organization:
Church Dwight Company Inc
Study Overview
Official Title:
A Multicentre Randomised Open Label Parallel Group Controlled Clinical Trial to Evaluate Efficacy and Tolerability of Two Seawater-based Formulations Plus a Standard of Care Versus the Standard of Care Alone for Relief of Nasal Congestion in Paediatric Subjects With Common Cold
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit 300 subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold
Detailed Description:
This clinical trial is a multicentre randomized parallel-group controlled open-label clinical trial to evaluate the efficacy of two Stérimar nasal sprays formulations medical device already CE marked for nasal congestion in children aged 3 to 48 months with common cold In total the study foresees 300 patients divided between the different clinical sites
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