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Secretin Infusion for Pain Due to Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01265875
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 1, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
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
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Human Secretin
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Uncooperative/unreliable             1
Arm/Group Title Human Secretin
Hide Arm/Group Description Human Secretin : Dose Escalation
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
42  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Hide Description 10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.
Time Frame Baseline, Days 1, 2, 3, 4, 7, 30.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Secretin
Hide Arm/Group Description:
Human Secretin : Dose Escalation
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.71  (1.45)
Day 1 Pre-dose 6.04  (2.13)
Day 1 Dose 1 (.05mcg/kg) 100min post dose 4.92  (2.20)
Day 1 Dose 2 (.1mcg/kg) 100 min post dose 4.87  (2.06)
Day 1 Dose 3 (.2mcg/kg) 100 min post dose 5.30  (2.19)
Day 1 Dose 3 (.2mcg/kg) 380 min post dose 4.64  (2.68)
Day 2 Pre-dose 5.33  (2.30)
Day 2 Dose 1 (.1mcg/kg) 100min post dose 5.25  (1.88)
Day 2 Dose 2 (.2mcg/kg) 100min post dose 5.50  (1.71)
Day 2 Dose 3 (.4mcg/kg) 100min post dose 4.67  (2.32)
Day 2 Dose 3 (.4mcg/kg) 380min post dose 4.77  (2.60)
Day 3 Pre-dose 4.92  (2.36)
Day 3 Dose 1 (.2mcg/kg) 100min post dose 4.58  (2.15)
Day 3 Dose 2 (.4mcg/kg) 100min post dose 4.33  (2.11)
Day 3 Dose 3 (.8mcg/kg) 100min post dose 5.17  (2.44)
Day 3 Dose 3 (.8mcg/kg) 380min post dose 4.71  (2.47)
Day 4 4.80  (2.49)
Day 7 5.18  (2.62)
Day 30 4.91  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Human Secretin
Comments Change from baseline to day 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .25
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Human Secretin
Comments Change from baseline to day 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .19
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Human Secretin
Comments Change from baseline to Day 30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .27
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Opiate Use at Baseline, Days 4 and 30.
Hide Description Daily opiate use (oral morphine equivalent).
Time Frame Baseline, Day 4, Day 30.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Secretin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/day
Baseline 139.6  (90.5)
Day 4 127.0  (99.2)
Day 30 97.2  (80.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Human Secretin
Comments Change from baseline to Day 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .52
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Human Secretin
Comments Change from baseline to Day 30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .34
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Quality of Life at Baseline, Day 4 and Day 30.
Hide Description Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Time Frame Baseline, Day 4, Day 30.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Secretin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 100.92  (5.26)
Day 4 100.9  (6.42)
Day 30 101.45  (5.68)
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events.
Hide Description [Not Specified]
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Secretin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title VAS Score at Each Administered Dose.
Hide Description 10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.
Time Frame Days 1, 2, and 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Secretin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-dose 6.04  (2.13)
.05 mcg/kg 4.92  (2.2)
.1 mcg/kg 5.06  (1.94)
.2 mcg/kg 4.92  (2.14)
.4 mcg/kg 4.5  (2.18)
.8 mcg/kg 5.36  (2.46)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human Secretin
Hide Arm/Group Description Human Secretin : Dose Escalation within participant
All-Cause Mortality
Human Secretin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Human Secretin
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Gastrointestinal disorders   
Pain, nausea, vomitting *  1/12 (8.33%)  1
epigastrium and right upper quadrant pain *  1/12 (8.33%)  1
Infections and infestations   
Central line infection (coagulase negative S. Aureus infection with bacteremia) * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Previous Hx central line infections. The SAE was related to a PICC line positioned in the R subclavian vein to provide the patient with TPN required by a Dx of CP related to alcohol abuse. Only subject in study with central line so only one at risk.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Human Secretin
Affected / at Risk (%) # Events
Total   9/12 (75.00%)    
Gastrointestinal disorders   
nausea, mild *  4/12 (33.33%) 
Vascular disorders   
mild flushing, upper body * [1]  6/12 (50.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Flushing is listed as a side effect in the package insert for human secretin.
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
Responsible Party: ChiRhoClin, Inc.
ClinicalTrials.gov 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