Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Disease
Keywords: Genetic End Marker
Lead sponsor: ChiRhoClin, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Ongoing, active pancreatitis at the time of the procedure.
2. Known adverse reaction to secretin.
3. Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
4. Use of anticholinergic medication within 7 days of study.
5. 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.
6. Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted.
7. Known complete obstruction of the pancreatic duct.
8. Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.

Primary outcomes:
measure: Endoscopic Sample
timeFrame: First 5 minutes after treatment administration
measure: Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
timeFrame: First 5 minutes after treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Frank Burton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: