Secretin Infusion for Pain Due to Chronic Pancreatitis

Completed · Phase 1/Phase 2

Conditions studied: Chronic Pancreatitis

In brief

* 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.

Key facts

Study ID

NCT01265875

Run by

ChiRhoClin, Inc.

People needed

12

Starts

2010-12-01

Expected to finish

2012-04-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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