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

Phase 3

Completed

Conditions: Sphincter of Oddi Dysfunction

Interventions: Drug: Duloxetine

Registration Number: NCT00471315

Lead Sponsor: Medical University of South Carolina

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	A preliminary, open-label single center study of duloxetine in patients with SOD

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.	3 months	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

Name	Time	Method
Toleration of the Medication as Measured by the Duloxetine Compliance Rate	3 Months	The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.