The Pancreatic Enzymes After Gastrectomy Trial

August 10, 2026 updated by: Albrecht Hoffmeister, University of Leipzig
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Borna, Germany
        • Recruiting
        • Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie
        • Contact:
      • Cottbus, Germany, 03048
        • Recruiting
        • Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
        • Contact:
      • Essen, Germany
        • Recruiting
        • KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie
        • Contact:
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf
        • Contact:
      • Heidelberg, Germany
      • Jena, Germany, 07740
        • Recruiting
        • Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
        • Contact:
      • Leipzig, Germany, 04103
        • Recruiting
        • Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
        • Contact:
      • Leipzig, Germany
        • Recruiting
        • Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie
        • Contact:
      • Nuremberg, Germany
        • Recruiting
        • Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Klinikum Nürnberg
        • Contact:
      • Tübingen, Germany
        • Recruiting
        • Klinik für Allgemeine-, Viszerale-, und Transplantationschirurgie; Universitätsklinikum Tübingen
        • Contact:
      • Ulm, Germany
        • Recruiting
        • Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gastrectomy (total and partial distal); at least > 50 % of the stomach must be resected
  2. Age 18 or older
  3. Written informed consent

Exclusion Criteria:

  1. Indication for pancreas enzyme therapy
  2. Gastrectomy with palliative intention
  3. UICC (Union for International Cancer Control) Stage IV gastric malignancy
  4. Malnutrition of other aetiology
  5. Life expectancy < 12 months
  6. Known lactose intolerance
  7. Known hereditary galactose intolerance
  8. Patients on alpha-glucosidase inhibitors (AGIs)
  9. Acute pancreatitis
  10. Acute episode of chronic pancreatitis
  11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
  12. Participation in competing interventional trials may be allowed under circumstances
  13. Patients under legal supervision or guardianship
  14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
  15. 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
  16. Pregnant or nursing women
  17. Suspected lack of compliance
  18. Patients who were already enrolled in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
10-15 capsules of placebo per day - over 6 months
Experimental: NORTASE®
Drug: NORTASE®
10-15 capsules of NORTASE® per day - over 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional supplementation or weight loss
Time Frame: 6 months
Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have > 10% weight loss at six months
6 months
Weight
Time Frame: 6 months
Percent weight-change at six months (weight in kilograms)
6 months
Serum haemoglobin
Time Frame: 6 months
Concentration of serum haemoglobin
6 months
Total protein
Time Frame: 6 months
Concentration of total protein
6 months
Albumin
Time Frame: 6 months
Concentration of albumin
6 months
Glucose
Time Frame: 6 months
Concentration of glucose
6 months
HbA1c
Time Frame: 6 months
Concentration of HbA1c
6 months
Cholesterol
Time Frame: 6 months
Concentration of cholesterol
6 months
Vitamin A
Time Frame: 6 months
Concentration of vitamin A
6 months
Vitamin B12
Time Frame: 6 months
Concentration of vitamin B12
6 months
Vitamin D
Time Frame: 6 months
Concentration of vitamin D
6 months
Vitamin E
Time Frame: 6 months
Concentration of vitamin E
6 months
Vitamin K
Time Frame: 6 months
Concentration of vitamin K
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Faecal elastase-1
Time Frame: 6 months
Concentration of faecal elastase-1
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Albrecht Hoffmeister, Prof. Dr., Universität Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PANEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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