A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
Phase 1
Terminated
- Conditions
- Chronic Pancreatitis
- Interventions
- Registration Number
- NCT01159119
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
- Detailed Description
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Diagnosis of Chronic Pancreatitis
- Exocrine Pancreatic Insufficiency
- Chronic abdominal pain
Exclusion Criteria
- Acute pancreatitis
- Active alcohol consumption
- Uncontrolled diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EUR-1066-B EUR-1066-B Treatment with Eur-1066-B EUR-1066-A EUR-1066-A Treatment with Eur-1006-A. Zenpep Zenpep Control Group: Consist of treatment with Zenpep
- Primary Outcome Measures
Name Time Method Comparing frequency and severity of pain up to 84 days Patient diary
- Secondary Outcome Measures
Name Time Method Changes in fat malabsorption up to 124 days Assess the coefficient of fat absorption
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which EUR-1066 modulates pancreatic exocrine function in chronic pancreatitis patients?
How does the efficacy of EUR-1066 compare to standard pancreatic enzyme replacement therapies like Zenpep in managing exocrine insufficiency and pain?
Which biomarkers correlate with improved symptom control in chronic pancreatitis patients treated with EUR-1066 formulations?
What adverse event profiles have been observed in phase 1 trials of pancreatic enzyme products for exocrine insufficiency?
Are there combination therapies involving EUR-1066 that enhance pain management in chronic pancreatitis with exocrine dysfunction?
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States
University of Florida🇺🇸Gainesville, Florida, United States