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  • Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis Rochester, Minn. The goal of the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models. Following are the objectives of the proposed clinical trial: Primary Objective: -To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients predicted to have moderately severe or severe AP. -To evaluate the efficacy of pirfenidone in reducing the laboratory markers of inflammation and improving patient reported outcome measures. Secondary Objective: - To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as measured by well-defined endpoints.
  • PROSPECTIVE EVALUATION OF CHRONIC PANCREATITIS FOR EPIDEMIOLOGIC AND TRANSLATIONAL STUDIES (THE PROCEED STUDY) (PROCEED) Rochester, Minn.

    The objectives of this study are to establish a model longitudinal research cohort of adult patients for the study of Chronic Pancreatitis (CP), its complications, to estimate the risk of progression from suspected to definite CP, and the risk of new-onset diabetes or exocrine insufficiency in definite CP, and study how the risks are influenced by patient characteristics and conditions, to test the predictive capability of candidate biomarkers for diagnosis and prognosis of CP, 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.

                                   
  • Safety, tolerability and dose limiting toxicity of lacosamide in patients with painful chronic pancreatitis. (STTEPP) (STTEPP) Rochester, Minn.

    The purpose of this study is to determine the safety, tolerability and dose-limiting toxicity of adding lacosamide to opioid therapy for the treatment of abdominal pain due to chronic pancreatitis (CP). Also, to assess the feasibility of performance of a pilot study adding lacosamide to opioid therapy in these subjects.

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  • A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort (NOD) Rochester, Minn., Mankato, Minn., La Crosse, Wis., Eau Claire, Wis.

    The purpose of this study is to establish a cohort of new onset diabetes patients.

     
  • Development and Feasibility Testing of An Internet-based Pain Self-management Program for Persons with Acute Recurrent and Chronic Pancreatitis Pain (The IMPACT study) (IMPACT) Rochester, Minn.

    The purpose of this study are 1) to refine an existing internet-delivered pain self-management program for use in adult chronic pancreatitis (CP) patients, and 2) to pilot its use in this patient population, generating preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial. 
  • Magnetic Resonance Imaging as a Non- Invasive Method for the Assessment of Pancreatic Fibrosis (MINIMAP) Rochester, Minn.

    The purpose of this study is to evaluate magnetic resonance imaging (MRI) as a non-invasive imaging method to detect chronic pancreatitis (CP) and quantify pancreatic fibrosis.
  • Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial (AP) Rochester, Minn.

    This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN.

    The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.

    Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission.

    Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.
  • Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial) Rochester, Minn.

    The purpose of this study is to assess the physiologic effect of orally administered indomethacin (IN) on pancreatic juice PGE2 concentrations in patients with chronic pancreatitis (CP).
  • Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies - PROCEED Study Rochester, Minn.

    The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).
  • Salivary Biomarkers of Chronic Pancreatitis: Pilot Study Rochester, Minn.

    The purpose of this study is to discover new ways of diagnosing chronic pancreatitis (CP) earlier in the course of the disease by studying molecules found in saliva.

     
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