A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

Completed · Phase 3 · Has a placebo group

Conditions studied: Pancreatic Disease

In brief

The following are the study hypothesis: * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.

Key facts

Study ID

NCT01087801

Run by

ChiRhoClin, Inc.

People needed

64

Starts

2007-10-01

Expected to finish

2009-12-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
• Undergoing Endoscopic Procedure.
• Age ≥ 18 years.
• Willing and able to sign informed consent, meeting IRB guidelines.
• Willing and able to meet all study requirements and obligations.

You may not qualify if…

• Ongoing, active pancreatitis at the time of the procedure.
• Known adverse reaction to secretin.
• Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
• Use of anticholinergic medication within 7 days of study.
• Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
• Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted.
• Known complete obstruction of the pancreatic duct.
• Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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