SODPilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).

Date de début de l'étude : 1 juillet 2006

INCLUSION CRITERIA: * Patients referred to MUSC pancreatico-biliary service for investigation/ mgt of functional upper abdominal pain symptoms; * No clinically significant medical condition(s) as determined by the investigator; * Symptom severity. At least 2 pain attacks in the previous month, with severity of at least 4/10 on the RAPID Start scale; * Prior cholecystectomy; * Age 18-65\*; * Functional pain characteristics as defined by Rome III Criteria; * Structural causes of pain excluded by standard imaging and laboratory investigations; * No clinically significant ECG results as determined by the investigator; * All patients will give verbal and written Informed consent; * Female patients must use an acceptable form of contraception, or be 2 years postmenopausal or surgically sterile\*; and * Geographically accessible for follow-up visits EXCLUSION CRITERIA: * History of/current psychosis, bipolar disorder, suicidal ideation or judged to be a significant suicide risk, as determined via baseline psychiatric assessment utilizing the MINI interview * History of alcohol or any psychoactive substance abuse or dependence within the past 6 months, as determined via baseline psychiatric assessment utilizing the MINI interview * Abnormal Liver Function Tests (\> 3 x ULN) * Known hypersensitivity to Duloxetine or any of the inactive ingredients * Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during study or within 5 days of discontinuation of study drug * Treatment with fluoxetine (deleted MAOI) within 30 days of medication start date * Treatment with excluded medications within 7 days prior to study medication start-up date * Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by study physician/investigator. * Uncontrolled narrow-angle glaucoma * Acute liver injury (such as hepatitis) or severe cirrhosis * Prior lack of tolerability to duloxetine * Pregnancy and breastfeeding Participation in the study is approximately 4 months. There are 4 clinic visits and 2 telephone visits.