NORTASE®
Drug10-15 capsules of NORTASE® per day - over 6 months
NCT Number: NCT06058442
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie, Borna, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10-15 capsules of NORTASE® per day - over 6 months
10-15 capsules of placebo per day - over 6 months
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).
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
Time frame: 6 months
Percent weight-change at six months (weight in kilograms)
Time frame: 6 months
Concentration of serum haemoglobin
Time frame: 6 months
Concentration of total protein
Time frame: 6 months
Concentration of albumin
Time frame: 6 months
Concentration of glucose
Time frame: 6 months
Concentration of HbA1c
Time frame: 6 months
Concentration of cholesterol
Time frame: 6 months
Concentration of vitamin A
Time frame: 6 months
Concentration of vitamin B12
Time frame: 6 months
Concentration of vitamin D
Time frame: 6 months
Concentration of vitamin E
Time frame: 6 months
Concentration of vitamin K
Time frame: 6 months
Concentration of faecal elastase-1
Contact information is provided by the study sponsor or research team.
University of Leipzig
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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