Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
188
Countries
1
Sites
12
Patients after gastrectomy (total and partial)
Can enzyme supplementation with every meal after gastrectomy lead to improved disease specific quality of life at 6 months after gastrectomy?
Key facts
- Sponsor
- University of Leipzig
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 2 Oct 2023 → ongoing
- Decision date (initial)
- 2023-04-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Can enzyme supplementation with every meal after gastrectomy lead to improved disease specific quality of life at 6 months after gastrectomy?
Conditions and MedDRA coding
Patients after gastrectomy (total and partial)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061965 | Gastrectomy | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Gastrectomy (total and partial) • Age 18 or older
Exclusion criteria 1
- • Indication for pancreas enzyme therapy • Gastrectomy with palliative intention • UICC (Union for International Cancer Control) Stage IV gastric malignancy • Malnutrition of other aetiology • Life expectancy < 12 months • Known lactose intolerance • Known hereditary galactose intolerance • Patients on alpha-glucosidase inhibitors (AGIs) • Acute pancreatitis • Acute episode of chronic pancreatitis • Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease specific quality of life (QOL) at 6 months according to the physical sub-score of the EORTC-QLQ-C30
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2642815 · Product
- Active substance
- Amylase
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 Other
- Max total dose
- 2700 Other
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- A09AA02 — MULTIENZYMES (LIPASE, PROTEASE ETC.)
- Marketing authorisation
- 7736.00.00
- MA holder
- REPHA GMBH BIOLOGISCHE ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding, study specific secondary packaging and labelling will be performed.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University of Leipzig
- Sponsor organisation
- University of Leipzig
- Address
- Ritterstraße 26, Zentrum Zentrum
- City
- Leipzig
- Postcode
- 04109
- Country
- Germany
Scientific contact point
- Organisation
- University of Leipzig
- Contact name
- legal representative
Public contact point
- Organisation
- University of Leipzig
- Contact name
- legal representative
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 188 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Im Neuenheimer Feld 672, Neuenheim, Heidelberg
Klinikum Nuernberg
Klinik für Allgemein- Viszeral- und Thoraxchirurgie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Medical Center - University Of Freiburg
Klinik für Allgemein- und Viszeralchirurgie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie, Henricistrasse 92, Huttrop, Essen
Klinikum St. Georg gGmbH
Klinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Delitzscher Strasse 141, Eutritzsch, Leipzig
Carl-Thiem-Klinikum Cottbus gGmbH
Klinik für Gastrenterologie und Rheumatologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
University Of Leipzig
Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie und Infektiologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Jena KöR
Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Ulm AöR
Klinik für Allgemein- und Viszeralchirurgie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Sana Kliniken Leipziger Land GmbH
Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie, Rudolf-Virchow-Strasse 2, 04552, Borna
University Medical Center Hamburg-Eppendorf
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Tuebingen AöR
Klinik für Allgemeine-, Viszerale-, und Transplantationschirurgie Tübingen, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-10-02 | 2024-01-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PANEM_protocol_p | 4 |
| Recruitment arrangements (for publication) | PANEM_recruitment | 1 |
| Subject information and informed consent form (for publication) | PANEM_subject information and informed consent form_1 | 2 |
| Subject information and informed consent form (for publication) | PANEM_subject information and informed consent form_1 | 4 |
| Subject information and informed consent form (for publication) | PANEM_subject information and informed consent form_2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PANEM_SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PANEM_SmPC | 2 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-20 | Germany | Acceptable 2023-04-21
|
2023-04-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-26 | Germany | Acceptable 2023-10-26
|
2023-11-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-18 | Germany | Acceptable | 2024-01-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-26 | Germany | Acceptable 2024-05-31
|
2024-06-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-12 | Germany | Acceptable 2024-05-31
|
2024-07-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-19 | Germany | Acceptable | 2024-09-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-14 | Germany | Acceptable | 2025-02-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-16 | Germany | Acceptable | 2025-05-23 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-08 | Germany | Acceptable | 2025-10-23 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-26 | Germany | Acceptable 2026-02-11
|
2026-02-12 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-03-24 | Germany | Acceptable | 2026-04-15 |