The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.

Condition	Treatment or Intervention	Phase
Bile Duct Diseases Biliary Tract Diseases Gallbladder Diseases Pancreatitis Pancreatic Diseases	Drug: IL-10	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

Adults weighing up to 125 kg who are undergoing ERCP for any of the following:

• Evaluate recurrent abdominal pain;
• Evaluate unexplained recurrent pancreatitis;
• Evaluate prior post-ERCP pancreatitis;
• Treatment of pancreatic disorders;
• Treatment of Common Bile Duct Stones (without jaundice)

Exclusion criteria:

• Active (acute) pancreatitis;
• Chronic pancreatitis (moderate and severe cases);
• ERCP to perform a second procedure on biliary tract;
• Patients who previously had pancreatic sphincterotomy;
• Known or suspected pancreatic cancer or cancer of Papilla of Vater;
• Known or suspected other malignancy;
• History of, or current clotting or bleeding problems;
• Moderate and severe Anemia;
• Low platelet counts

California
      Interventional Endoscopy Services, San Francisco,  California,  94118,  United States
      Cedars Sinai Medical Center - G.I. Department, Los Angeles,  California,  90048,  United States
Colorado
      Rocky Mountain Gastroenterology Associates, Lakewood,  Colorado,  80215,  United States
      University of Colorado Hospital, Aurora,  Colorado,  80010,  United States
      Outpatient Pavilion, Aurora,  Colorado,  United States
Florida
      University of Florida, Gainesville,  Florida,  32610,  United States
Indiana
      Indiana University Medical Center, Indianapolis,  Indiana,  46202,  United States
Iowa
      University of Iowa - Dept. of Internal Medicine, Iowa City,  Iowa,  52242,  United States
Kentucky
      University of Kentucky, Lexington,  Kentucky,  40536,  United States
Maryland
      Digestive Disorders Associates, Annapolis,  Maryland,  21401,  United States
Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      Oakland Gastroenterology Associates, Southfield,  Michigan,  48034,  United States
Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55415,  United States
      Mayo Clinic El, Rochester,  Minnesota,  55905,  United States
Missouri
      Division of Gastroenterology, St. Louis,  Missouri,  63110,  United States
      St. Louis University - Div. of GI/Hep., St. Louis,  Missouri,  63104,  United States
New York
      Maimonides Medical Center, Brooklyn,  New York,  11219,  United States
      Digestive Health Physician, Cheektowaga,  New York,  14225,  United States
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States
      Beth Israel North, New York,  New York,  10028,  United States
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States
North Carolina
      Duke University Medical School, Durham,  North Carolina,  27710,  United States
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
Pennsylvania
      Division of Gastroenterology, Pittsburg,  Pennsylvania,  15212,  United States
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States
      Penn State University, Hershey,  Pennsylvania,  17033,  United States
Virginia
      Richmond GI Research Group, Richmond,  Virginia,  23230,  United States
Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States
Wisconsin
      Gastroenterology Consultants, Milwaukee,  Wisconsin,  53215,  United States
Austria
      Univ. of Clinic of Vienna, Vienna,  Austria
Belgium
      Hospital Erasme ULB, Bruelles,  Belgium
      UZ Gasthuisberg, Leuven,  Belgium
Chile
      Clinica Santa Maria, Santiago,  Chile
France
      A.P.H. Paris, Hopital Bicetre, Bicetre,  France
      Hospices Civils de Lyon, Hopital Edouard Herriot, Lyon,  France
Italy
      Policlinico Gemelli, Rome,  Italy
      Ospedale San Raffaele, Milan,  Italy
United Kingdom
      Queens Medical Center, Nottingham,  United Kingdom

Study ID Numbers:  P02580
Record last reviewed:  January 2002
Last Updated:  October 13, 2004
Record first received:  June 20, 2002
ClinicalTrials.gov Identifier:  NCT00040131
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08