Clinical trials: Pancreatic Exocrine Insufficiency
Cystic Fibrosis, Pancreatic Insufficiency
Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.
- Trial name
- NCT00095732
- Testing
- Liprotamase
- Where
- 27 sites in United States
- Volunteers
- 129 people
- Sponsor
- Anthera Pharmaceuticals
Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease
Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs
This is a Phase 2 study sponsored by AzurRx SAS and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF).
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease, Cystic Fibrosis of Pancreas
- Trial name
- NCT04302662
- Testing
- MS1819-SD
- Where
- 10 sites in Hungary, Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- AzurRx SAS
Cystic Fibrosis, Pancreatic Exocrine Insufficiency
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
- Trial name
- NCT00775528
- Testing
- Pancrelipase Delayed Release
- Where
- 12 sites in United States
- Volunteers
- 19 people
- Sponsor
- Solvay Pharmaceuticals
Exocrine Pancreatic Insufficiency
Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.
- Trial name
- NCT00749099
- Testing
- pancrelipase
- Volunteers
- 11 people
- Sponsor
- Digestive Care, Inc.
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional…
- Trial name
- NCT04966897
- Testing
- Standard Nutritional Supplement + PERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- GlycosBio, Inc.
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
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
Oral CDX-7108 in Healthy Adults and EPI Subjects
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency.
- Trial name
- NCT05082051
- Testing
- Part A, Part B, Part C
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration…
- Trial name
- SIMPLICITY (NCT02734810)
- Testing
- Liprotamase Powder for Oral Solution
- Where
- 21 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anthera Pharmaceuticals
Chronic Pancreatitis, Pancreatectomy
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy.
- Conditions
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- Trial name
- NCT00414908
- Testing
- Pancrelipase delayed release capsule
- Where
- 30 sites in United States, Bulgaria and 6 more
- Volunteers
- 52 people
- Sponsor
- Solvay Pharmaceuticals
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT04375878
- Testing
- MS1819, Porcine PERT
- Where
- 15 sites in United States, Poland
- Volunteers
- 27 people
- Sponsor
- Entero Therapeutics
Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)
The purpose of the study is to evaluate the enzyme activity and safety of pancrelipase in patients with severe Exocrine Pancreatic Insufficiency (EPI)
- Conditions
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic, Steatorrhea, Pancreatitis
- Trial name
- NCT00676702
- Testing
- Ensure Plus, Pancrelipase in combination with Ensure Plus
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Fibrosing Colonopathy
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of…
- Trial name
- NCT01652157
- Testing
- ULTRESA, PANCREAZE, CREON
- Where
- 123 sites in United States
- Volunteers
- 17 people
- Sponsor
- AbbVie
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
PR-018: An Open-Label, Safety Extension of Study PR-011
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT01131507
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
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
Chronic Pancreatitis, Healthy Volunteers
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
- Trial name
- NCT01259544
- Testing
- benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
- Where
- India
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.