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

Phase 3

Completed

• Conditions: Pancreatic Disease
• Interventions: Drug: ChiRhoStim; Drug: Placebo

• Registration Number: NCT01087801
• Lead Sponsor: ChiRhoClin, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Results First Submitted: 2011-06-07
• Results First Submitted QC: 2011-10-26
• Status Verified: 2011-12
• Results First Posted: 2011-12-02
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChiRhoStim	ChiRhoStim	Human Secretin for Injection
Placebo	Placebo	Saline for Injection

Primary Outcome Measures

Name	Time	Method
Endoscopic Sample	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).
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).	First 5 minutes after treatment administration	Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States