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

Pancreatic Disease Clinical Trial

— CRC2006-05  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087801
• Other study ID #: 2006-05
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2010
• Last updated: December 2, 2011
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: ChiRhoClin, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases

Intervention

Drug:
• ChiRhoStim
Human Secretin for Injection
• Placebo
Saline for Injection

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ChiRhoClin, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Sample	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).	First 5 minutes after treatment administration	No
Primary	Volume of Fluid = 3.5mL (Boolean Expression Evaluated as Yes or no).	Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.	First 5 minutes after treatment administration	No