Clinical trials: Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a…
- Trial name
- NCT00400842
- Testing
- SA-001
- Where
- 98 sites in Japan
- Volunteers
- 274 people
- Sponsor
- Abbott
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.
Metabolic Disorder; Carbohydrate, Absorption, Intestine
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
- Trial name
- NCT02538653
- Testing
- Sandwich biscuit high in SDS, Co-extruded cereal low in SDS
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Exocrine Pancreatic Insufficiency (EPI)
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected…
- Trial name
- NCT03859869
- Testing
- Pancrelipase
- Where
- 33 sites in United States
- Volunteers
- 1 people
- Sponsor
- AbbVie
Chronic Pancreatitis, Distal Pancreatectomy
A Phase IIa Study With Escalating Dose of MS1819-SD
This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic…
- Trial name
- NCT03481803
- Testing
- MS1819-SD
- Where
- 6 sites in Australia, France and 1 more
- Volunteers
- 11 people
- Sponsor
- AzurRx SAS
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Open-Label Phase III Long-Term Safety Trial of Liprotamase
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
- Trial name
- DIGEST (NCT00449904)
- Testing
- Liprotamase
- Where
- 39 sites in United States
- Volunteers
- 214 people
- Sponsor
- Anthera 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, Chronic Pancreatitis
Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially…
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic Fibrosis
- Trial name
- NCT00744250
- Testing
- Pancrelipase
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Digestive Care, Inc.
Pancreatic Insufficiency
Equivalence Study to Compare Two Strengths of Creon in China
This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules…
- Trial name
- CREON (NCT03450772)
- Testing
- Creon® 25000, Creon® 10000
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Abbott
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes.
- Trial name
- NCT03051490
- Testing
- Liprotamase, porcine PERT
- Where
- 50 sites in United States, Hungary and 5 more
- Volunteers
- 140 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
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
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories
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
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
Pancreatic Insufficiency
Creon After Pancreatic Surgery
This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA
- Trial name
- NCT00535756
- Testing
- Creon
- Where
- 15 sites in Bulgaria, Germany and 2 more
- Volunteers
- 58 people
- Sponsor
- Abbott Products
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.
Pancreatic Exocrine Insufficiency
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
- Trial name
- NCT01747330
- Testing
- Pancreatin
- Where
- 9 sites in Russia
- Volunteers
- 40 people
- Sponsor
- Abbott Products
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP)…
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Trial name
- NCT00559364
- Testing
- Viokase® 16, Proton pump inhibitor (PPI), Omeprazole
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Forest Laboratories
Chronic Pancreatitis, Exocrine Pancreatic Insufficiency
A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment…
- Trial name
- NCT00788593
- Testing
- EUR-1008 (APT-1008) High Dose, EUR-1008 (APT-1008) Low Dose
- Where
- 18 sites in United States, Italy and 1 more
- Volunteers
- 82 people
- Sponsor
- Forest Laboratories