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

NCT01087801 | Completed Phase 3 Results

• 1 other identifier: 2006-05
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Disease

Keywords

Genetic End Marker

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

ChiRhoStim

ACTIVE COMPARATOR

Human Secretin for Injection

Drug: ChiRhoStim

Placebo

PLACEBO COMPARATOR

Saline for Injection

Drug: Placebo

Interventions

ChiRhoStim DRUG

Human Secretin for Injection

ChiRhoStim

Placebo DRUG

Saline for Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChiRhoClin, Inc.: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Edward Purich, Ph.D.
• Organization: ChiRhoClin, Inc.

mdoerr@chirhoclin.com

301-476-8388

Study Officials

• Frank Burton, M.D.

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: October 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 6, 2011
• Results First Posted: December 2, 2011

Record last verified: 2011-12

Locations

US (1)