Status:
COMPLETED
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
Lead Sponsor:
Medical University of South Carolina
Conditions:
Sphincter of Oddi Dysfunction
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 Duloxeti...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00471315
Start Date
July 1 2006
End Date
March 1 2012
Last Update
February 6 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Digestive Disease Center, Medical University of South Carolina
Charleston, South Carolina, United States, 29425