Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
Condition: Sphincter of Oddi Dysfunction
MeSH terms: Sphincter of Oddi Dysfunction
Intervention: Duloxetine
Intervention description: A preliminary, open-label single center study of duloxetine in patients with SOD
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SOD; Common Bile Duct Diseases; Sphincterotomy; Cholangiopancreatography, Endoscopic Retrograde

Summary:

      Open-label single center study of duloxetine in patients with SOD who have failed to respond
      to the standard treatments.

      This protocol is designed to explore the tolerability and efficacy of Duloxetine in the
      management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
    

Eligibility criteria:

        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.