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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 mea
  Sponsor: Medical University of South Carolina
  

  Current Primary Outcome: The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. [ Time Frame: 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.
  
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome: Toleration of the Medication as Measured by the Duloxetine Compliance Rate [ Time Frame: 3 Months ]

  The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
  
  
  

  Original Secondary Outcome:
  
  Information By: Medical University of South Carolina
  

  Dates:
  Date Received: May 8, 2007
  Date Started: July 2006
  Date Completion:
  Last Updated: December 18, 2013
  Last Verified: February 2009