SODPilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).
Duloxetine
Bile Duct Diseases+3
+ Biliary Dyskinesia
+ Biliary Tract Diseases
Treatment Study
Summary
Study start date: July 1, 2006
Actual date on which the first participant was enrolled.SOD is a disorder involving the bile duct or pancreas causing a burning pain or cramping in the epigastric (upper stomach) area that can radiate (spread) to the back or under the right shoulder blade. This discomfort is thought to be caused by tightening of the Sphincter of Oddi, which is the muscle opening that controls the flow of bile and juices from the pancreas (enzymes) into the small intestine. It can also be caused by contractions of the common bile duct (the duct that allows bile from the liver into the small intestine). The purpose of this research is to study how well a medication called Duloxetine works when used to treat pain associated with SOD. Duloxetine (also called Cymbalta) is a medication approved by the FDA for the treatment of depression and for the treatment of pain caused by nerve damage associated with diabetes. However, for the purposes of this research, Duloxetine is considered investigational (experimental) since it will test how well this medication works for the treatment of pain associated with SOD. (Cymbalta replaced with Duloxetine in remainder of consent as requested). PRIMARY OBJECTIVE ● Treatment effect as measured by the global assessment of change (PGIC) after 3 months of treatment with duloxetine. SECONDARY OBJECTIVES * Toleration of the medication as measured by the duloxetine compliance rate; * Safety as recorded by adverse events (AEs) * Effect of treatment on pain reduction as measured by a pain burden assessment tool (RAPID 3 \& RAPID 1-Month); * Effect of treatment on quality of life (QOL) as measured by the SF-36.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Digestive Disease Center, Medical University of South Carolina
Charleston, United StatesOpen Digestive Disease Center, Medical University of South Carolina in Google Maps