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

NCT00471315 | Completed Phase 3 Results

• 1 other identifier: HR16489
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Sphincter of Oddi Dysfunction

Keywords

SOD; Common Bile Duct Diseases; Sphincterotomy; Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Toleration of the Medication as Measured by the Duloxetine Compliance Rate

  3 Months

Study Arms (1)

Duloxetine

NO INTERVENTION

A preliminary, open-label single center study of duloxetine in patients with SOD

Drug: Duloxetine

Interventions

Duloxetine DRUG

A preliminary, open-label single center study of duloxetine in patients with SOD

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Digestive Disease Center, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Links

• MUSC Digestive Disease Center Website

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction; Common Bile Duct Diseases

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Biliary Dyskinesia; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Most frequently reported adverse events included fatigue, nausea, headaches, constipation, decreased appetite and insomnia at primarily mild to moderate severity.

Results Point of Contact

• Title: Peter Cotton, MD
• Organization: Medical University of South Carolina

CottonP@MUSC.edu

(843) 792-6999

Study Officials

• Christopher Lawrence, MD

  MUSC Digestive Disease Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: July 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2009-02

Locations

US (1)