Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study)
Principle Investigator: Evan Fogel, MD
To establish a model longitudinal research cohort of adult patients for the study of chronic pancreatitis and its complications.
To estimate the risk of progression from suspected to definite chronic pancreatitis, and the risk of new-onset diabetes or exocrine insufficiency in definite chronic pancreatitis, and how the risks are influenced by patient characteristics and conditions.
To test the predictive capability of candidate biomarkers for diagnosis and prognosis of chronic pancreatitis.
To develop a framework for conducting biomarker, genetic, and mechanistic studies using clinical information and the biorepository developed as part of the longitudinal research cohort.
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPIRE 2)
Principle Investigator: Brian McFerron, MD
Primary Objective: To comprehensively characterize the pediatric population with Acute Recurrent Pancreatitis (ARP) and Chronic Pancreatitis (CP) and determine predictors of early onset CP and its sequelae.
Predicting treatment response in Chronic Pancreatitis using Quantitative Sensory Testing
Principle Investigator: Benjamin Bick, MD
Primary Objective: To distinguish phenotypes characterized by segmental sensitization of the pancreatic viscerotome, and systematic sensitization with pathological central pain processing including augmented temporal summation and impaired descending pain inhibition.
A Phase 1, Single Dose PK and Safety Study with NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 Compared to Placebo in Subjects with Chronic Pancreatitis
Principle Investigator: Glen Lehman, MD
Primary Objective: To determine the efficacy, PK and safety of three doses of NI-03 (100mg, 200mg, and 300mg) as compared to placebo when administered three times daily (TID) for 28 consecutive days in subjects with chronic pancreatitis.