Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction) (SOD)
Primary Purpose
Sphincter of Oddi Dysfunction
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Sphincter of Oddi Dysfunction focused on measuring SOD, Common Bile Duct Diseases, Sphincterotomy, Cholangiopancreatography, Endoscopic Retrograde
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.
Sites / Locations
- Digestive Disease Center, Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Duloxetine
Arm Description
A preliminary, open-label single center study of duloxetine in patients with SOD
Outcomes
Primary Outcome Measures
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
Secondary Outcome Measures
Toleration of the Medication as Measured by the Duloxetine Compliance Rate
The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
Full Information
NCT ID
NCT00471315
First Posted
May 8, 2007
Last Updated
December 18, 2013
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00471315
Brief Title
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
Acronym
SOD
Official Title
Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sphincter of Oddi Dysfunction
Keywords
SOD, Common Bile Duct Diseases, Sphincterotomy, Cholangiopancreatography, Endoscopic Retrograde
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
No Intervention
Arm Description
A preliminary, open-label single center study of duloxetine in patients with SOD
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
A preliminary, open-label single center study of duloxetine in patients with SOD
Primary Outcome Measure Information:
Title
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
Description
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Toleration of the Medication as Measured by the Duloxetine Compliance Rate
Description
The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Lawrence, MD
Organizational Affiliation
MUSC Digestive Disease Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Disease Center, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ddc.musc.edu/
Description
MUSC Digestive Disease Center Website
Learn more about this trial
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
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