Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-07 @ 5:29 PM
Study NCT ID:
NCT04700293
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Sponsor:
Aymes International Limited
Organization:
Study Overview
Official Title:
Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Status:
COMPLETED
Status Verified Date:
2021-01
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:
None
Brief Summary:
To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description:
To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.
To obtain data to support an ACBS submissions for 'AMSTERDAM' (to allow for prescription in the community at NHS expense).
To obtain data to support an ACBS submissions for 'AMSTERDAM' (to allow for prescription in the community at NHS expense).
Study Oversight
Has Oversight DMC:
False
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?: