GastrectomyPhase 3NCT06058442
The Pancreatic Enzymes After Gastrectomy Trial
A Phase 3 study testing NORTASE® in people with Gastrectomy, run by University of Leipzig at 12 sites in Germany.
Trial summary
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy
- What is being tested?
- NORTASE®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 12 sitesGermany
- Study dates
- 24 Jan 2024to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastrectomy (total and partial distal); at least > 50 % of the stomach must be resected
- Age 18 or older
- Written informed consent
Who cannot join
- 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
Show all 18Show fewer
- 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®
- Participation in competing interventional trials may be allowed under circumstances
- Patients under legal supervision or guardianship
- Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
- Pregnant or nursing women
- Suspected lack of compliance
- Patients who were already enrolled in the trial
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Albrecht Hoffmeister, Prof. Dr. contact
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie
Borna
Kay Kohlhaw, PD Dr., +49 3433 21-1501, Kay.Kohlhaw@Sana.de
- Recruiting
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
Cottbus, 03048
Tobias Kleemann, Dr., +493554679427, t.kleemann@ctk.de
- Recruiting
KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie
Essen
Christian Müller, Dr., +49 201 174-24001, Ch.Mueller@kem-med.com
- Recruiting
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
Freiburg im Breisgau, 79106
Jasmina Kuvendjiska, Dr., +4976127024010, jasmina.kuvendjiska@uniklinik-freiburg.de
- Recruiting
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf
Hamburg
Felix Nickel, Prof., +4915228842335, f.nickel@uke.de
- Recruiting
Chirurgische Universitätsklinik, Universitätsklinikum Heidelberg
Heidelberg
Henrik Nienhüser, PD Dr., +4962215634919, Henrik.Nienhueser@med.uni-heidelberg.de
- Recruiting
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
Jena, 07740
Michael Ardelt, PD Dr. Dr., +4936419322675, michael.ardelt@med.uni-jena.de
- Recruiting
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
Leipzig, 04103
Albrecht Hoffmeister, Prof. Dr., +4934197 ext. 12240, Albrecht.Hoffmeister@medizin.uni-leipzig.de
- Recruiting
Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie
Leipzig
Boris Jansen-Winkeln, PD Dr., +49 341 909-2200, allgemein-viszeralchirurgie@sanktgeorg.de
- Recruiting
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Klinikum Nürnberg
Nuremberg
Patrick Heger, Dr., +49911398114417, patrick.heger@klinikum-nuernberg.de
- Recruiting
Klinik für Allgemeine-, Viszerale-, und Transplantationschirurgie; Universitätsklinikum Tübingen
Tübingen
Felix Berlth, Dr., +4970712987291, felix.berlth@med-uni-tuebingen.de
- Recruiting
Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm
Ulm
Patrick Téoule, PD Dr., +49 731-5000, patrick.teoule@uniklinik-ulm.de
About this study
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
- Conditions
- Gastrectomy
- Being tested
- NORTASE®, Placebo
- Keywords
- enzyme supplementation, lipase, elastase, gastrointestinal, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NORTASE®Drug
10-15 capsules of NORTASE® per day - over 6 months
PlaceboDrug
10-15 capsules of placebo per day - over 6 months
| Study group | Role | What they receive |
|---|---|---|
| NORTASE® | Experimental | Not described Receives: Drug: NORTASE® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific quality of life (QOL)
This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).
Measured: 6 months
Secondary outcomes (13)
Nutritional supplementation or weight loss
Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have > 10% weight loss at six months
Measured: 6 months
Weight
Percent weight-change at six months (weight in kilograms)
Measured: 6 months
Serum haemoglobin
Concentration of serum haemoglobin
Measured: 6 months
Total protein
Concentration of total protein
Measured: 6 months
Albumin
Concentration of albumin
Measured: 6 months
Glucose
Concentration of glucose
Measured: 6 months
HbA1c
Concentration of HbA1c
Measured: 6 months
Cholesterol
Concentration of cholesterol
Measured: 6 months
Vitamin A
Concentration of vitamin A
Measured: 6 months
Vitamin B12
Concentration of vitamin B12
Measured: 6 months
Vitamin D
Concentration of vitamin D
Measured: 6 months
Vitamin E
Concentration of vitamin E
Measured: 6 months
Vitamin K
Concentration of vitamin K
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start24 Jan 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albrecht Hoffmeister, University of Leipzig
- Investigators
- Albrecht Hoffmeister, Prof. Dr., Principal investigator, Universität Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058442
- Sponsor's protocol ID
- PANEM
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thomas K, Ackmann C, Schmiedeknecht A, Scheibe K, Kleemann T, Ardelt M, Dondorf F, Radulova-Mauersberger O, Kuvendjiska J, Hipp J, Jansen-Winkeln B, Bley T, Wetzold U, Sporn J, Peters F, Teoule P, Birgin E, Petroff D, Hoffmeister A. Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy. PLoS One. 2026 Sep 22;21(9):e0358177. doi: 10.1371/journal.pone.0358177. eCollection 2026.
PubMed 42771661
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pancreatic Enzymes After Gastrectomy Trial
- ClinicalTrials.gov ID
- NCT06058442
- Acronym / sponsor ID
- PANEM
- Conditions
- Gastrectomy
- Keywords
- enzyme supplementation, lipase, elastase, gastrointestinal, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NORTASE® | Experimental | Drug: NORTASE® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gastrectomy (total and partial distal); at least > 50 % of the stomach must be resected
- Age 18 or older
- Written informed consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NORTASE®10-15 capsules of NORTASE® per day - over 6 months | Drug | NORTASE® |
| Placebo10-15 capsules of placebo per day - over 6 months | Drug | Placebo |
Primary outcome
Disease specific quality of life (QOL)
Time frame: 6 months
This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).
13 secondary outcomes
Nutritional supplementation or weight loss
Time frame: 6 months
Weight
Time frame: 6 months
Serum haemoglobin
Time frame: 6 months
Total protein
Time frame: 6 months
Albumin
Time frame: 6 months
Glucose
Time frame: 6 months
HbA1c
Time frame: 6 months
Cholesterol
Time frame: 6 months
Vitamin A
Time frame: 6 months
Vitamin B12
Time frame: 6 months
Vitamin D
Time frame: 6 months
Vitamin E
Time frame: 6 months
Vitamin K
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42771661Thomas K, Ackmann C, Schmiedeknecht A, Scheibe K, Kleemann T, Ardelt M, Dondorf F, Radulova-Mauersberger O, Kuvendjiska J, Hipp J, Jansen-Winkeln B, Bley T, Wetzold U, Sporn J, Peters F, Teoule P, Birgin E, Petroff D, Hoffmeister A. Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy. PLoS One. 2026 Sep 22;21(9):e0358177. doi: 10.1371/journal.pone.0358177. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albrecht Hoffmeister, Prof. Dr. contact
Albrecht Hoffmeister, Prof. Dr. principal investigator
Universität Leipzig
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NORTASE® in people with Gastrectomy, run by University of Leipzig at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albrecht Hoffmeister, Prof. Dr. (+4934197 ext. 12240, Albrecht.Hoffmeister@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific quality of life (QOL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.