Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
38
Countries
1
Sites
1
Oesophagectomy
To elucidate how route of nutrition impacts cachexia after oesophagostomy
Key facts
- Sponsor
- Aarhus Universitet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-01-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Aarhus University · Novo Nordisk Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To elucidate how route of nutrition impacts cachexia after oesophagostomy
Secondary objectives 1
- To elucidate how route of nutrition affects postoperative complications and quality of life
Conditions and MedDRA coding
Oesophagectomy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Scheduled for elective oesophagectomy at the Department of Thoracic Surgery, Aarhus University Hospital. Included procedures: Oesophagectomy (scopic procedure) with gastric pull-up. Distal oesophagectomy with total gastrectomy and other reconstructive procedures (duodenum or colon) Total oesophagectomy with colon anastomosis in the neck area. Eligible for both enteral and TPN. Age ≥ 18 years
Exclusion criteria 1
- Lack of consent Women of childbearing age without negative pregnancy test Known allergy or intolerance to any of the included drugs Diagnosed with primary skeletal muscle disease that could influence muscle wasting according to the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean difference in muscle size assessed by CT-scan from before to 10 days after oesophagostomy
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SmofKabiven emulsion for infusion
PRD707630 · Product
- Active substance
- Valine
- Pharmaceutical form
- EMULSION FOR INFUSION
- Route of administration
- PARENTERAL USE
- Max daily dose
- 9 Other
- Max total dose
- 9 Other
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA10 — COMBINATIONS
- Marketing authorisation
- PL 08828/0187
- MA holder
- FRESENIUS KABI LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus Universitet
- Sponsor organisation
- Aarhus Universitet
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus Universitet
- Contact name
- Henrik Hovgaard
Public contact point
- Organisation
- Aarhus Universitet
- Contact name
- Henrik Hovgaard
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 38 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-02 | Denmark | Acceptable with conditions 2024-01-15
|
2024-01-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-29 | Denmark | Acceptable with conditions 2024-01-15
|
2024-02-29 |