Clinical trials: Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI).
- Trial name
- SPAN (NCT05719311)
- Testing
- adrulipase
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Entero Therapeutics
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
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
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and…
- Trial name
- NCT00297167
- Testing
- EUR-1008 (APT-1008)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories
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
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
Chronic Pancreatitis
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea.
- Trial name
- CisCP (NCT04949828)
- Testing
- CREON
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- AbbVie
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
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
EASY: Extended Access to Sollpura Over Years
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
- NCT02823964
- Testing
- Liprotamase
- Where
- 15 sites in United States, Czechia and 4 more
- Volunteers
- 25 people
- Sponsor
- Anthera Pharmaceuticals
Exocrine Pancreatic Insufficiency
Phase III ALTU-135 CP Safety Trial
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).
- Trial name
- DIGEST CP (NCT00500084)
- Testing
- Liprotamase
- Where
- 11 sites in United States
- Volunteers
- 39 people
- Sponsor
- Anthera Pharmaceuticals
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine…
- Trial name
- NCT00401076
- Testing
- SA-001
- Where
- 17 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Abbott
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
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.
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