Secretin Infusion for Pain Due to Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265875
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 1, 2016
Last Update Posted : March 9, 2016
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
ChiRhoClin, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Pancreatitis
Intervention: Drug: Human Secretin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Human Secretin

Human Secretin : Dose Escalation

There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits.

Participant Flow:   Overall Study
    Human Secretin
Uncooperative/unreliable                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.
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Reporting Groups
Human Secretin Human Secretin : Dose Escalation

Baseline Measures
   Human Secretin 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 42  (9.7) 
[Units: Participants]
Female   6 
Male   6 
Region of Enrollment 
[Units: Participants]
United States   12 

  Outcome Measures

1.  Primary:   VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.   [ Time Frame: Baseline, Days 1, 2, 3, 4, 7, 30. ]

2.  Primary:   Opiate Use at Baseline, Days 4 and 30.   [ Time Frame: Baseline, Day 4, Day 30. ]

3.  Primary:   Quality of Life at Baseline, Day 4 and Day 30.   [ Time Frame: Baseline, Day 4, Day 30. ]

4.  Secondary:   Number of Participants With Serious Adverse Events.   [ Time Frame: 30 Days ]

5.  Secondary:   VAS Score at Each Administered Dose.   [ Time Frame: Days 1, 2, and 3. ]

  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
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  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: Timothy Gardner, MD
Organization: Dartmouth-Hitchcock Medical Center
phone: 603-650-6472

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: ChiRhoClin, Inc. Identifier: NCT01265875     History of Changes
Other Study ID Numbers: 2010-01
First Submitted: December 22, 2010
First Posted: December 23, 2010
Results First Submitted: July 29, 2013
Results First Posted: March 1, 2016
Last Update Posted: March 9, 2016