CompletedNCT01265875Updated Mar 9, 2016Results posted

Secretin Infusion for Pain Due to Chronic Pancreatitis

A Phase 1/2 interventional study of Human Secretin in Chronic Pancreatitis, sponsored by ChiRhoClin, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by ChiRhoClin, Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 12
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Chronic Pancreatitis

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Keywords

Chronic Pancreatitis

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

ChiRhoClin, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female, between the ages of 18-70 years old.
Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.
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.
If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.
Negative serum pregnancy within 72 hours of secretin administration.
Use of opioid analgesics for chronic pain from CP.
Willing and able to sign written informed consent.

Exclusion criteria

Exclusion Criteria:

Male or female \<18 or >70 years of age.
Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.
Exhibiting signs and/or symptoms of an episode of acute pancreatitis.
Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
Severe renal disease (history of acute or chronic renal failure, dialysis dependent, baseline creatinine >2.0 mg/dL).
Previous adverse drug event to intravenous secretin.
Ongoing illicit drug use or abuse.
Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine and/or 1 oz liquor /day.
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.
Prior pancreatic surgery.
Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.
Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.
Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.
Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.
Unwilling or unable to give written, informed consent.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

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

Interventions

DrugHuman Secretin
Dose Escalation
Also known as: ChiRhoStim

What researchers measure

Primary outcomes

VAS Score at 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.
Time frame: Baseline, Days 1, 2, 3, 4, 7, 30.
Opiate Use at Baseline, Days 4 and 30.
Daily opiate use (oral morphine equivalent).
Time frame: Baseline, Day 4, Day 30.
Quality of Life at Baseline, Day 4 and Day 30.
Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Time frame: Baseline, Day 4, Day 30.

Secondary outcomes

Number of Participants With Serious Adverse Events.
Time frame: 30 Days
VAS Score at Each Administered Dose.
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.

Results

Posted Mar 1, 2016

Participant flow

Participant flow — Overall Study
Milestone	Human Secretin
Started	12
Completed	11
Not completed	1
Withdrew: Uncooperative/unreliable	1

Outcome measures

PrimaryVAS Score at 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.

Time frame:: Baseline, Days 1, 2, 3, 4, 7, 30.
Reported as:: Mean · units on a scale

VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
units on a scale	Human Secretin
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

Human Secretin · t-test, 2 sided · p = .25
Human Secretin · t-test, 2 sided · p = .19
Human Secretin · t-test, 2 sided · p = .27

SecondaryNumber of Participants With Serious Adverse Events.

Time frame:: 30 Days
Reported as:: Number · participants

Number of Participants With Serious Adverse Events.
participants	Human Secretin
Number of Participants With Serious Adverse Events.	3

PrimaryOpiate Use at Baseline, Days 4 and 30.

Daily opiate use (oral morphine equivalent).

Time frame:: Baseline, Day 4, Day 30.
Reported as:: Mean · mg/day

Opiate Use at Baseline, Days 4 and 30.
mg/day	Human Secretin
Baseline	139.6 ± 90.5
Day 4	127.0 ± 99.2
Day 30	97.2 ± 80.5

Statistical analysis

Human Secretin · t-test, 2 sided · p = .52
Human Secretin · t-test, 2 sided · p = .34

PrimaryQuality of Life at Baseline, Day 4 and Day 30.

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

Time frame:: Baseline, Day 4, Day 30.
Reported as:: Mean · units on a scale

Quality of Life at Baseline, Day 4 and Day 30.
units on a scale	Human Secretin
Baseline	100.92 ± 5.26
Day 4	100.9 ± 6.42
Day 30	101.45 ± 5.68

SecondaryVAS Score at Each Administered Dose.

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.
Reported as:: Mean · units on a scale

VAS Score at Each Administered Dose.
units on a scale	Human Secretin
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

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Human Secretin	—	3/12 (25%)	9/12 (75%)

Most frequent serious events

Most frequent serious events
Event	Human Secretin
Central line infection (coagulase negative S. Aureus infection with bacteremia)Infections and infestations	1/1
Pain, nausea, vomittingGastrointestinal disorders	1/12
epigastrium and right upper quadrant painGastrointestinal disorders	1/12

Most frequent other events

Most frequent other events
Event	Human Secretin
mild flushing, upper bodyVascular disorders	6/12
nausea, mildGastrointestinal disorders	4/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Human Secretin
<=18 years	0
Between 18 and 65 years	12
>=65 years	0

Age, Continuous
Age, Continuous(years)	Human Secretin
Mean	42 ± 9.7

Sex: Female, Male
Sex: Female, Male(Participants)	Human Secretin
Female	6
Male	6

Region of Enrollment
Region of Enrollment(participants)	Human Secretin
United States	12

Study locations

1 site

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States

References and documents

Publications

Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec. Erratum In: Pancreas. 2016 May-Jun;45(5):e23. doi: 10.1097/MPA.0000000000000664.. Dosage error in article text. PubMed 23548879 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01265875
Lead sponsor: ChiRhoClin, Inc.
Collaborators: Dartmouth-Hitchcock Medical Center
Responsible party: Sponsor
First posted: Dec 23, 2010
Start date: Dec 2010
Primary completion: Dec 2011
Completion: Apr 2012
Results posted: Mar 1, 2016
Last update: Mar 9, 2016

Study contacts

Timothy B Gardner, M.D.

principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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