Secretin Infusion for Pain Due to Chronic Pancreatitis

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

• Male or female 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.