Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction) (SOD)

Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).

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).

Study Overview

• Status: Completed
• Conditions: Sphincter of Oddi Dysfunction
• Intervention / Treatment: Drug: Duloxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Digestive Disease Center, Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Duloxetine; A preliminary, open-label single center study of duloxetine in patients with SOD	Drug: Duloxetine; A preliminary, open-label single center study of duloxetine in patients with SOD; Other Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 Months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Christopher Lawrence, MD, MUSC Digestive Disease Center

Publications and helpful links

Helpful Links

• MUSC Digestive Disease Center Website

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 8, 2007
• First Submitted That Met QC Criteria: May 8, 2007
• First Posted (Estimate): May 9, 2007

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: SOD; Sphincterotomy; Common Bile Duct Diseases; Cholangiopancreatography, Endoscopic Retrograde
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Dyskinesia; Common Bile Duct Diseases; Sphincter of Oddi Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: HR16489