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

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ClinicalTrials.gov Identifier: NCT00471315
Recruitment Status : Completed
First Posted : May 9, 2007
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sphincter of Oddi Dysfunction
Intervention Drug: Duloxetine
Enrollment 18

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
Period Title: Overall Study
Started 18
Completed 10
Not Completed 8
Reason Not Completed
Adverse Event             7
Withdrawal by Subject             1
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
43.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
12
  66.7%
Male
6
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (1.32)
2.Secondary Outcome
Title Toleration of the Medication as Measured by the Duloxetine Compliance Rate
Hide Description The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
Time Frame 3 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine
Hide Arm/Group Description:
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine
Hide Arm/Group Description Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
All-Cause Mortality
Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine
Affected / at Risk (%) # Events
Total   11/18 (61.11%)    
Gastrointestinal disorders   
Constipation   4/18 (22.22%)  4
Decreased appetite   4/18 (22.22%)  4
General disorders   
Fatigue   11/18 (61.11%)  11
Nausea   10/18 (55.56%)  10
Headaches   5/18 (27.78%)  5
Insomnia   4/18 (22.22%)  4
Indicates events were collected by systematic assessment
Most frequently reported adverse events included fatigue, nausea, headaches, constipation, decreased appetite and insomnia at primarily mild to moderate severity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Cotton, MD
Organization: Medical University of South Carolina
Phone: (843) 792-6999
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00471315     History of Changes
Other Study ID Numbers: HR16489
First Submitted: May 8, 2007
First Posted: May 9, 2007
Results First Submitted: October 23, 2013
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014