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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00471315
First received: May 8, 2007
Last updated: December 18, 2013
Last verified: February 2009
  Purpose

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).


Condition Intervention Phase
Sphincter of Oddi Dysfunction
Drug: Duloxetine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.


Enrollment: 18
Study Start Date: July 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cymbalta

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471315

Locations
United States, South Carolina
Digestive Disease Center, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Christopher Lawrence, MD MUSC Digestive Disease Center
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00471315     History of Changes
Other Study ID Numbers: HR16489
Study First Received: May 8, 2007
Results First Received: October 23, 2013
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
SOD
Common Bile Duct Diseases
Sphincterotomy
Cholangiopancreatography, Endoscopic Retrograde

Additional relevant MeSH terms:
Sphincter of Oddi Dysfunction
Bile Duct Diseases
Biliary Dyskinesia
Biliary Tract Diseases
Common Bile Duct Diseases
Digestive System Diseases
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014