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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06058442
Other study ID # PANEM
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 24, 2024
Est. completion date April 2026

Study information

Verified date March 2024
Source University of Leipzig
Contact Albrecht Hoffmeister, Prof. Dr.
Phone 004934197
Email Albrecht.Hoffmeister@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 188
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Gastrectomy (total and partial) 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 NORTASEĀ® 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
NORTASE®
10-15 capsules of NORTASE® per day - over 6 months
Placebo
10-15 capsules of placebo per day - over 6 months

Locations

Country Name City State
Germany Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik Cottbus
Germany Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden
Germany Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie Jena
Germany Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig Leipzig

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Faecal elastase-1 Concentration of faecal elastase-1 6 months
Primary 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 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 6 months
Secondary Weight Percent weight-change at six months (weight in kilograms) 6 months
Secondary Serum haemoglobin Concentration of serum haemoglobin 6 months
Secondary Total protein Concentration of total protein 6 months
Secondary Albumin Concentration of albumin 6 months
Secondary Glucose Concentration of glucose 6 months
Secondary HbA1c Concentration of HbA1c 6 months
Secondary Cholesterol Concentration of cholesterol 6 months
Secondary Vitamin A Concentration of vitamin A 6 months
Secondary Vitamin B12 Concentration of vitamin B12 6 months
Secondary Vitamin D Concentration of vitamin D 6 months
Secondary Vitamin E Concentration of vitamin E 6 months
Secondary Vitamin K Concentration of vitamin K 6 months
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