Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)

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.