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Completed

NCT Number: NCT01087801

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint Louis University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ChiRhoStim

Drug

Human Secretin for Injection

Placebo

Drug

Saline for Injection

Primary outcomes

  1. Endoscopic Sample

    Time frame: First 5 minutes after treatment administration

    Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).

    (Note- The outcome value is boolean (yes or no) as an answer).

  2. Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).

    Time frame: First 5 minutes after treatment administration

    Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.

Sponsors and collaborators

Lead sponsor

ChiRhoClin, Inc.

Industry

Registry information

Official study title

A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

Acronym: CRC2006-05

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 16, 2010
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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