Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-20 @ 1:58 AM
Study NCT ID:
NCT02648451
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Tolerance Study of New Oral Nutritional Supplement
Sponsor:
Aymes International Limited
Organization:
Study Overview
Official Title:
Tolerance and Acceptability of AYMES ROME
Status:
COMPLETED
Status Verified Date:
2016-01
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 AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
* To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
Detailed Description:
To evaluate tolerance and acceptability of AYMES ROME 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 AYMES ROME (to allow for prescription in the community at NHS expense).
To obtain data to support an ACBS submissions for AYMES ROME (to allow for prescription in the community at NHS expense).
Study Oversight
Has Oversight DMC:
False
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?: