Secretin Infusion for Pain Due to Chronic Pancreatitis

• 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.

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Drug: Human Secretin

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
11. Prior pancreatic surgery.
12. Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.
13. Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.
14. Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.
15. Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.
16. Unwilling or unable to give written, informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Days 1, 2, 3, 4, 7, 30.
Opiate Use at Baseline, Days 4 and 30.	Daily opiate use (oral morphine equivalent).	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.	Baseline, Day 4, Day 30.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events.		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.	Days 1, 2, and 3.

Collaborators and Investigators

• Sponsor: ChiRhoClin, Inc.
• Collaborators: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Timothy B Gardner, M.D., Dartmouth-Hitchcock Medical Center

Publications and helpful links

General 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. Dosage error in article text.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Chronic Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Secretin
• Other Study ID Numbers: 2010-01 (internal number)