Study of NORTASE4 Treatment Compared to Standard Care in Adults After Gastrectomy Surgery

What this Trial Is About

Researchers are evaluating the effects of NORTASE42, a pancreatic enzyme treatment, compared to standard care in patients who have undergone gastrectomy, which involves removal of part or all of the stomach. The study focuses on how these treatments affect patients quality of life and weight over time. This Phase 3 trial is randomized and double-blinded to compare the two groups fairly. Participants will receive either 10 to 15 capsules of NORTASE42 or a placebo each day for six months. This treatment period allows researchers to assess the impact of the enzyme therapy after gastrectomy. The trial includes patients who had at least 50% of their stomach removed and excludes those with other conditions or treatments that could interfere. During the study, participants will be monitored for various health measures including disease-specific quality of life, weight, nutritional supplementation, blood levels of haemoglobin, proteins, glucose, cholesterol, and vitamins A, B12, D, E, and K. These assessments occur over the six-month treatment period to evaluate how the interventions affect overall health. Safety and compliance are also tracked throughout the trial.

The Pancreatic Enzymes After Gastrectomy Trial