Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfu… (NCT00471315) | Clinical Trial Compass
CompletedPhase 3
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
United States18 participantsStarted 2006-07
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.