A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01159119
• Date of registration: 05/07/2010
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain EUR-1066
• Scientific title: Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain
• Date of first enrolment: August 2, 2010
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01159119
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Phillip Toskes, MD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Chronic Pancreatitis

- Exocrine Pancreatic Insufficiency

- Chronic abdominal pain

Exclusion Criteria:

- Acute pancreatitis

- Active alcohol consumption

- Uncontrolled diabetes



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Drug: EUR-1066-A

Drug: Zenpep

Drug: EUR-1066-B

Primary Outcome(s)

Comparing frequency and severity of pain [Time Frame: up to 84 days]

Secondary Outcome(s)

Changes in fat malabsorption [Time Frame: up to 124 days]

Secondary ID(s)

PR-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Florida