Secretin Infusion for Pain Due to Chronic Pancreatitis

• Sponsor: ChiRhoClin, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01265875
• Collaborator: Dartmouth-Hitchcock Medical Center (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

• To determine if intravenous secretin administration in escalating doses three times daily for three days will improve the pain from CP at the time of infusion, after each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.

• To validate the safety of intravenous secretin administration at the dosage indicated in this study.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Drug: Human Secretin	Phase 1/Phase 2

Detailed Description

12 patients will be enrolled in this study. Patients will be only those treated at Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must be taking prescribed opioid analgesics for the specific treatment of CP at the time of study enrollment. Only patients between the ages of 18-70 and capable of providing informed consent will be considered eligible for the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Secretin Infusion for Pain Due to Chronic Pancreatitis
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: human secretin intravenous secretin administration in escalating doses three times daily for three days. After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.	Drug: Human Secretin; Dose Escalation; Other Names: ChiRhoStim

Outcome Measures

Primary Outcome Measures

1. VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. [Baseline, Days 1, 2, 3, 4, 7, 30.]

   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.

2. Opiate Use at Baseline, Days 4 and 30. [Baseline, Day 4, Day 30.]

   Daily opiate use (oral morphine equivalent).

3. Quality of Life at Baseline, Day 4 and Day 30. [Baseline, Day 4, Day 30.]

   Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.

Secondary Outcome Measures

1. Number of Participants With Serious Adverse Events. [30 Days]

2. VAS Score at Each Administered Dose. [Days 1, 2, and 3.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female, between the ages of 18-70 years old.

2. Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.

3. If female, and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.

4. If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.

5. Negative serum pregnancy within 72 hours of secretin administration.

6. Use of opioid analgesics for chronic pain from CP.

7. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Male or female <18 or >70 years of age.

2. Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.

3. Exhibiting signs and/or symptoms of an episode of acute pancreatitis.

4. Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).

5. Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).

6. Severe renal disease (history of acute or chronic renal failure, dialysis dependent, baseline creatinine >2.0 mg/dL).

7. Previous adverse drug event to intravenous secretin.

8. Ongoing illicit drug use or abuse.

9. Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine and/or 1 oz liquor /day.

10. Acute pancreatitis as defined by the Atlanta Classification definition (refer to Table

1. within the previous two months or symptoms consistent with ongoing acute pancreatitis.

1. Prior pancreatic surgery.

2. Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.

3. Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.

4. Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.

5. Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.

6. Unwilling or unable to give written, informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• ChiRhoClin, Inc.
• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Timothy B Gardner, M.D., Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ChiRhoClin, Inc.
• ClinicalTrials.gov Identifier: NCT01265875
• Other Study ID Numbers: 2010-01
• First Posted: Dec 23, 2010
• Last Update Posted: Mar 9, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by ChiRhoClin, Inc.: Chronic Pancreatitis
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Secretin

Study Results

Participant Flow

Arm/Group Title	Human Secretin
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

Baseline Characteristics

Arm/Group Title	Human Secretin
Arm/Group Description	Human Secretin : Dose Escalation
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (9.7)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Human Secretin
Arm/Group Description	Human Secretin : Dose Escalation
Measure Participants	12
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)

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
Statistical Test of Hypothesis	p-Value	.25
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	.19
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	.27
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Number of Participants With Serious Adverse Events.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Human Secretin
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.
Measure Participants	12
Number [participants]	3 25%

3. Primary Outcome

Title	Opiate Use at Baseline, Days 4 and 30.
Description	Daily opiate use (oral morphine equivalent).
Time Frame	Baseline, Day 4, Day 30.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Human Secretin
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.
Measure Participants	12
Baseline	139.6 (90.5)
Day 4	127.0 (99.2)
Day 30	97.2 (80.5)

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
Statistical Test of Hypothesis	p-Value	.52
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	.34
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Quality of Life at Baseline, Day 4 and Day 30.
Description	Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Time Frame	Baseline, Day 4, Day 30.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Human Secretin
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.
Measure Participants	12
Baseline	100.92 (5.26)
Day 4	100.9 (6.42)
Day 30	101.45 (5.68)

5. Secondary Outcome

Title	VAS Score at Each Administered Dose.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Human Secretin
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.
Measure Participants	12
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)

Adverse Events

Arm/Group Title	Human Secretin
Arm/Group Description	Human Secretin : Dose Escalation within participant
All Cause Mortality
	Human Secretin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Human Secretin
	Affected / at Risk (%)	# Events
Total	3/12 (25%)
Gastrointestinal disorders
Pain, nausea, vomitting	1/12 (8.3%)	1
epigastrium and right upper quadrant pain	1/12 (8.3%)	1
Infections and infestations
Central line infection (coagulase negative S. Aureus infection with bacteremia)	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	Human Secretin
	Affected / at Risk (%)	# Events
Total	9/12 (75%)
Gastrointestinal disorders
nausea, mild	4/12 (33.3%)
Vascular disorders
mild flushing, upper body	6/12 (50%)

Limitations/Caveats

[Not Specified]

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.