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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Duloxetine Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.

Participant Flow:   Overall Study
    Duloxetine
STARTED   18 
COMPLETED   10 
NOT COMPLETED   8 
Adverse Event                7 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duloxetine Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.

Baseline Measures
   Duloxetine 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.7  (10.3) 
Gender 
[Units: Participants]
 
Female   12 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.   [ Time Frame: 3 months ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Most frequently reported adverse events included fatigue, nausea, headaches, constipation, decreased appetite and insomnia at primarily mild to moderate severity.


  More Information

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
e-mail: CottonP@MUSC.edu



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