Ongoing Clinical Trials for Pancreatic Failure
There are currently 3 ongoing clinical trials investigating pancreatic enzyme replacement therapy for patients with pancreatic failure, primarily focusing on improving digestion and nutritional status in patients who have undergone pancreatic or stomach surgery, or who have advanced pancreatic cancer. These trials are being conducted across several European countries including Spain, Sweden, Italy, Germany, Poland, and Portugal.
Clinical trial locations
- Germany
- Italy
- Poland
- Portugal
- Spain
- Study on Pancreas Powder for Digestive Issues in Patients with Unresectable Pancreatic Cancer
- Study on Pancreatic Enzyme Replacement Therapy for Adults with Pancreatic Exocrine Insufficiency After Pancreatic Surgery
- Study on the Effect of Pancreatic Enzyme Replacement Therapy with Pancreas Powder in Patients with Pancreatic Exocrine Insufficiency After Total Gastrectomy
- Sweden
Study on Pancreas Powder for Digestive Issues in Patients with Unresectable Pancreatic Cancer
This trial is investigating whether pancreatic enzyme replacement therapy can help patients with advanced pancreatic cancer who are experiencing digestive problems due to insufficient enzyme production by their pancreas. The condition, known as pancreatic exocrine insufficiency, leads to poor digestion and weight loss.
Who can participate:
- Adults over 18 years of age
- People with unresectable pancreatic cancer located in the head of the pancreas that is either locally advanced or has spread to other parts of the body
- Those with a dilated main pancreatic duct confirmed by imaging tests
- Patients who have lost at least 5% of their usual body weight
- Those with a life expectancy of at least six months
Who cannot participate:
- Patients with conditions other than pancreatic exocrine insufficiency
- Those who have had surgery to remove their pancreatic cancer
- Individuals who belong to vulnerable populations
What the trial involves: Participants will receive Kreon 35,000 U, a medication containing pancreatic enzymes in capsule form. The study lasts six months and involves regular monitoring of weight, nutritional status, blood markers like haemoglobin and cholesterol, digestive symptoms, and quality of life. The goal is to determine whether this therapy can help patients gain weight, improve their nutrition, and better tolerate chemotherapy treatments.
Investigational treatment: Pancreatic Enzyme Replacement Therapy using Kreon, which contains digestive enzymes that help break down food when the pancreas is not functioning properly.
Study on Pancreatic Enzyme Replacement Therapy for Adults with Pancreatic Exocrine Insufficiency After Pancreatic Surgery
This trial focuses on patients who have had their entire pancreas removed in a procedure called total pancreatectomy. After this surgery, the body can no longer produce digestive enzymes naturally, leading to significant digestive challenges.
Who can participate:
- Men and women of any ethnic background aged 18 to 80 years
- Those who have had a total pancreatectomy at least 2 weeks before the study begins
- Patients with moderate symptoms of pancreatic exocrine insufficiency, including at least one abnormal lab test showing nutritional deficit
- Those taking or willing to start taking proton pump inhibitors to reduce stomach acid
- Individuals with a life expectancy matching the length of the study
What the trial involves: Participants will take Creon 35,000, a pancreatic enzyme replacement therapy, in capsule form with meals. The study will monitor whether patients need doses higher than 70,000 units per main meal to manage their condition effectively. Regular assessments will track nutritional status, body weight, quality of life, diabetes parameters, and any side effects. Participants will maintain an electronic diary to record symptoms, stool frequency, and any treatment-related issues.
Investigational treatment: Creon 35,000, which contains digestive enzymes including lipase, protease, and amylase that help break down fats, proteins, and carbohydrates.
Study on the Effect of Pancreatic Enzyme Replacement Therapy with Pancreas Powder in Patients with Pancreatic Exocrine Insufficiency After Total Gastrectomy
This trial examines patients who have developed pancreatic exocrine insufficiency after having their entire stomach removed in a procedure called total gastrectomy. This surgery can affect the pancreas’s ability to produce digestive enzymes, leading to malnutrition and weight loss.
Who can participate:
- Men and women of any ethnic background aged 18 to 80 years
- Those who have undergone total gastrectomy
- Patients with pancreatic exocrine insufficiency confirmed by symptoms and a fecal elastase test
- Individuals who have not received chemotherapy or radiotherapy in the week before joining the study
- Those who have not used any investigational treatments in the three months before the study
Who cannot participate:
- Patients who have not had a total gastrectomy
- Those who do not have pancreatic exocrine insufficiency
- Individuals belonging to vulnerable populations
What the trial involves: Participants will take Creon 25,000 capsules orally to manage their digestive symptoms. The primary goal is to maintain nutritional status and prevent weight loss. The study will monitor body weight, nutritional parameters, symptoms of pancreatic exocrine insufficiency, and gastrointestinal quality of life through questionnaires. Participants will keep diaries to track symptoms and any side effects. The study is expected to conclude by June 2026.
Investigational treatment: Creon 25,000, a pancreatic enzyme replacement therapy that helps digest food by providing the enzymes that the pancreas is no longer producing.
Summary
All three ongoing clinical trials focus on the use of pancreatic enzyme replacement therapy to manage pancreatic exocrine insufficiency in different patient populations. The trials are concentrated in Southern and Central European countries, with Spain participating in all three studies, demonstrating significant research activity in this area. Poland and Germany are also involved in multiple trials.
The studies share a common therapeutic approach using Creon products at various strengths (25,000 U, 35,000 U) to supplement missing digestive enzymes. Each trial targets a specific patient group: those with unresectable pancreatic cancer, those who have undergone total pancreatectomy, and those who have had total gastrectomy. The primary goals across all trials include maintaining or improving nutritional status, preventing weight loss, and enhancing quality of life for patients struggling with digestive problems due to insufficient pancreatic enzyme production.