NCT06058442

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
13mo left

Started Jan 2024

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2024Jun 2027

First Submitted

Initial submission to the registry

September 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

September 8, 2023

Last Update Submit

January 19, 2026

Conditions

Gastrectomy

Keywords

enzyme supplementationlipaseelastasegastrointestinalquality of life

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (13)

  • Nutritional supplementation or weight loss

    6 months

  • Weight

    6 months

  • Serum haemoglobin

    6 months

  • Total protein

    6 months

  • Albumin

    6 months

  • +8 more secondary outcomes

Other Outcomes (1)

  • Faecal elastase-1

    6 months

Study Arms (2)

NORTASE®

EXPERIMENTAL
Drug: NORTASE®

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NORTASE®DRUG

10-15 capsules of NORTASE® per day - over 6 months

NORTASE®
PlaceboDRUG

10-15 capsules of placebo per day - over 6 months

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastrectomy (total and partial); at least \> 50 % of the stomach must be resected
  • Age 18 or older
  • Written informed consent

You may not qualify if:

  • 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®
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie

Borna, Germany

NOT YET RECRUITING

Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik

Cottbus, 03048, Germany

RECRUITING

KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie

Essen, Germany

NOT YET RECRUITING

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie

Jena, 07740, Germany

RECRUITING

Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie

Leipzig, Germany

RECRUITING

Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie

Schwerin, 19055, Germany

RECRUITING

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

MeSH Terms

Interventions

nortase

Study Officials

  • Albrecht Hoffmeister, Prof. Dr.

    Universität Leipzig

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albrecht Hoffmeister, Prof. Dr.

CONTACT

+4934197Albrecht.Hoffmeister@medizin.uni-leipzig.de

Anett Schmiedeknecht, Dr.

CONTACT

+49 34197anett.schmiedeknecht@zks.uni-leipzig.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 28, 2023

Study Start

January 24, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

DE(9)