Table of Contents
- Trial overview
- Study after gastrectomy
- Study in exocrine pancreatic insufficiency
- Main outcomes measured
- Who can participate
- Trial phases and status
- What these trials add
Trial overview
Two authorised clinical trials are investigating Amylase-related enzyme treatment in different patient groups.[1][2] Both studies are interventional, which means the researchers give a study treatment and then measure what happens.[1][2]
The first trial studies people after gastrectomy, which means surgery to remove all or part of the stomach.[1] The second trial studies adults with exocrine pancreatic insufficiency, a condition where the pancreas does not make enough digestive enzymes.[2]
Study after gastrectomy
The trial titled The Pancreatic Enzymes after Gastrectomy Trial is a Phase 3 study with 188 participants.[1] It includes patients after total or partial gastrectomy and is comparing Nortase® with placebo to test whether enzyme supplementation with every meal can improve disease-specific quality of life.[1]
The main question is whether taking enzymes with meals can help patients feel better six months after surgery.[1] The study uses the physical part of the EORTC-QLQ-C30, a questionnaire that measures how a person is doing in daily life and physical function.[1]
Study in exocrine pancreatic insufficiency
The second trial is a Phase 2 study in 44 adult participants with exocrine pancreatic insufficiency.[2] It compares a new lipase product, NHS7108, with pancrelipase in oral capsule form.[2]
This study is focused on safety and early signs of efficacy, which means whether the treatment may work as expected.[2] The treatment period is 14 days, and the study is designed to see how participants respond during that time.[2]
Main outcomes measured
The gastrectomy trial mainly measures disease-specific quality of life at 6 months, using the physical sub-score of the EORTC-QLQ-C30.[1] This helps show whether the treatment improves daily physical well-being after surgery.[1]
The exocrine pancreatic insufficiency trial measures three main safety outcomes: the number of participants with one or more adverse events, changes in safety tests, and changes in the coefficient of nitrogen absorption after 14 days.[2] Safety tests include laboratory tests, vital signs, 12-lead ECG, and physical examination.[2]
These outcomes help researchers see both how safe the study treatment is and whether digestion-related measures change during treatment.[2]
Who can participate
One study is for patients after total or partial gastrectomy, so the target group is people who have had stomach surgery.[1] The other study is for adult participants with exocrine pancreatic insufficiency.[2]
Because the trials study different conditions, the participant groups are not the same.[1][2] This is important because clinical research often needs a very specific group of patients to answer the study question clearly.[1][2]
Trial phases and status
The gastrectomy study is in Phase 3, which usually means a larger study that compares treatment effects in a more advanced research stage.[1] The exocrine pancreatic insufficiency study is in Phase 2, which usually looks at safety and early benefit signals.[2]
Both studies are listed as authorised, meaning they have approval to proceed.[1][2] Together, they show that Amylase-related research is being tested in both post-surgical care and digestive insufficiency settings.[1][2]
What these trials add
These trials are not just looking at whether treatment is given, but at what matters to patients, such as physical quality of life and day-to-day safety.[1][2] They also use measurable study tools, like questionnaires, laboratory tests, and absorption measures, to track changes over time.[1][2]
By studying different patient groups, the research can help show how Amylase-related treatment may be used in specific digestive conditions.[1][2]
