In short
Clinical trials investigating Amylase are studying enzyme-based treatments in people after gastrectomy and in adults with exocrine pancreatic insufficiency. These trials look at safety, quality of life, and how well treatment works in real patients. The studies include Phase 2 and Phase 3 research.
Key points
- Clinical trials investigating Amylase are focused on enzyme-based treatment in two patient groups: people after gastrectomy and adults with exocrine pancreatic insufficiency. One study is Phase 3 and looks at quality of life after surgery, while the other is Phase 2 and focuses on safety plus early signs of benefit. The trials are authorised and use oral study treatments. The main outcomes include quality of life, adverse events, safety checks, and nitrogen absorption. Together, these studies aim to understand whether treatment can help patients digest food better and feel better in daily life.
Trial overview
Two authorised clinical trials are investigating Amylase-related enzyme treatment in different patient groups. Both studies are interventional, which means the researchers give a study treatment and then measure what happens.
The first trial studies people after gastrectomy, which means surgery to remove all or part of the stomach. The second trial studies adults with exocrine pancreatic insufficiency, a condition where the pancreas does not make enough digestive enzymes.
Study after gastrectomy
The trial titled The Pancreatic Enzymes after Gastrectomy Trial is a Phase 3 study with 188 participants. 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.
The main question is whether taking enzymes with meals can help patients feel better six months after surgery. 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.
Study in exocrine pancreatic insufficiency
The second trial is a Phase 2 study in 44 adult participants with exocrine pancreatic insufficiency. It compares a new lipase product, NHS7108, with pancrelipase in oral capsule form.
This study is focused on safety and early signs of efficacy, which means whether the treatment may work as expected. The treatment period is 14 days, and the study is designed to see how participants respond during that time.
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. This helps show whether the treatment improves daily physical well-being after surgery.
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. Safety tests include laboratory tests, vital signs, 12-lead ECG, and physical examination.
These outcomes help researchers see both how safe the study treatment is and whether digestion-related measures change during treatment.
Who can participate
One study is for patients after total or partial gastrectomy, so the target group is people who have had stomach surgery. The other study is for adult participants with exocrine pancreatic insufficiency.
Because the trials study different conditions, the participant groups are not the same. This is important because clinical research often needs a very specific group of patients to answer the study question clearly.
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. The exocrine pancreatic insufficiency study is in Phase 2, which usually looks at safety and early benefit signals.
Both studies are listed as authorised, meaning they have approval to proceed. Together, they show that Amylase-related research is being tested in both post-surgical care and digestive insufficiency settings.
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. They also use measurable study tools, like questionnaires, laboratory tests, and absorption measures, to track changes over time.
By studying different patient groups, the research can help show how Amylase-related treatment may be used in specific digestive conditions.