Clinical trials: Pancreatic Exocrine Insufficiency
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI.
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality, Pancreatic Diseases
- Trial name
- EPIC (NCT07559175)
- Testing
- NHS7108, Zenpep®
- Where
- 39 sites in United States, Bulgaria and 5 more
- Volunteers
- 66 people
- Sponsor
- Aimmune Nestlé Health Science US R&D, LLC
Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to…
- Trial name
- PRECISE (NCT02370537)
- Testing
- Epanova® (omega-3 carboxylic acids), Omacor® (omega-3-acid ethyl esters)
- Where
- 22 sites in Denmark, Hungary and 4 more
- Volunteers
- 490 people
- Sponsor
- AstraZeneca
Exocrine Pancreatic Insufficiency
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.
- Trial name
- NCT00559052
- Testing
- VIOKASE 16
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Axcan Pharma
Cystic Fibrosis
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine…
- Trial name
- NCT03924947
- Testing
- Pancrelipase
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- AbbVie
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Background: Chronic pancreatitis (CP) is a progressive inflammatory disorder causing irreversible pancreatic damage, eventually resulting in pancreatic exocrine insufficiency (PEI).
- Trial name
- NP-PERT (NCT07697352)
- Testing
- Dietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)., Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)
- Where
- India
- Volunteers
- 134 people
- Sponsor
- Asian Institute of Gastroenterology, India
Bone Marrow Failure Syndrome, Severe Aplastic Anemia
CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation
This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the…
- Conditions
- Bone Marrow Failure Syndrome, Severe Aplastic Anemia, Severe Congenital Neutropenia, Amegakaryocytic Thrombocytopenia
- Trial name
- NCT01966367
- Testing
- CD34 Stem Cell Selection Therapy
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Diane George
Pancreatic Adenocarcinoma
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules)…
- Trial name
- PANCAX-3 (NCT04098237)
- Testing
- Pancrelipase
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Andrew Hendifar, MD
Chronic Pancreatitis
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.
- Trial name
- NCT00957151
- Testing
- Creon
- Volunteers
- 12 people
- Sponsor
- Hospital Avicenne
Pancreatic Exocrine Insufficiency, Adul
A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based…
- Trial name
- NCT07751367
- Testing
- High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet, Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL
- Trial name
- NCT00743483
- Testing
- rhBSSL
- Where
- 4 sites in Netherlands, Poland
- Volunteers
- 15 people
- Sponsor
- Swedish Orphan Biovitrum
Cystic Fibrosis, Pancreatic Insufficiency
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan).
- Trial name
- NCT00513682
- Testing
- Ultrase® MT20
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Forest Laboratories
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2
A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
- Trial name
- NCT02009410
- Testing
- Creon
- Where
- 10 sites in Germany, Spain
- Sponsor
- Abbott
Pancreatic Insufficiency, Cystic Fibrosis
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
- Conditions
- Pancreatic Insufficiency, Cystic Fibrosis, Digestive System Diseases, Lung Diseases
- Trial name
- NCT01710644
- Testing
- Burlulipase
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Nordmark Arzneimittel GmbH & Co. KG
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00408317
- Testing
- Ultrase® MT20
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forest Laboratories
Exocrine Pancreatic Insufficiency
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis.
- Trial name
- PERT-AP (NCT06477159)
- Testing
- Pancrelipase Capsules
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ohio State University
Cystic Fibrosis, Pancreatic Insufficiency
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop.
- Trial name
- NCT01851694
- Testing
- GLP-1, GIP
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Cystic Fibrosis Related Diabetes, Pancreatic Insufficiency
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the…
- Trial name
- NCT00763412
- Testing
- repaglinide
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Arbelaez, Ana Maria
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Chronic Pancreatitis
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
- Trial name
- EUR-1066 (NCT01159119)
- Testing
- EUR-1066-A, Zenpep, EUR-1066-B
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Exocrine Pancreatic Insufficiency
Registry of Pancreatic Exocrine Insufficiency: Enzyme Dose Requirements and Outcomes in Pancreatic Exocrine Insufficiency Across Aetiologies
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom.
- Trial name
- EURO-PEI regis (NCT05450627)
- Testing
- Pancreatic Enzyme
- Where
- Spain
- Volunteers
- 1,015 people
- Sponsor
- Hospital Clinico Universitario de Santiago