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 (CRC2006-05)

ChiRhoClin

Status and phase: Completed; Phase 3

Conditions: Pancreatic Disease

Treatments: Drug: ChiRhoStim; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01087801

2006-05

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

ChiRhoStim

Active Comparator group

Description:

Human Secretin for Injection

Treatment:

Drug: ChiRhoStim

Placebo

Placebo Comparator group

Description:

Saline for Injection

Treatment:

Drug: Placebo