Clinical trial NCT01265875: Secretin Infusion for Pain Due to Chronic Pancreatitis
Official title: Secretin Infusion for Pain Due to Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pancreatitis
Keywords: Chronic Pancreatitis
Lead sponsor: ChiRhoClin, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dartmouth-Hitchcock Medical Center
First posted: 2010-12-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
timeFrame: Baseline, Days 1, 2, 3, 4, 7, 30.
measure: Opiate Use at Baseline, Days 4 and 30.
timeFrame: Baseline, Day 4, Day 30.
measure: Quality of Life at Baseline, Day 4 and Day 30.
timeFrame: Baseline, Day 4, Day 30.
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events.
timeFrame: 30 Days
measure: VAS Score at Each Administered Dose.
timeFrame: Days 1, 2, and 3.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Timothy B Gardner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.