Back to resultsA 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)
Primary Purpose
Pancreatic Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ChiRhoStim
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Disease focused on measuring Genetic End Marker
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Saint Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ChiRhoStim
Placebo
Arm Description
Human Secretin for Injection
Saline for Injection
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087801
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChiRhoClin, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Disease
Keywords
Genetic End Marker
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ChiRhoStim
Arm Type
Active Comparator
Arm Description
Human Secretin for Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline for Injection
Intervention Type
Drug
Intervention Name(s)
ChiRhoStim
Intervention Description
Human Secretin for Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline for Injection
Primary Outcome Measure Information:
Title
Endoscopic Sample
Description
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).
Time Frame
First 5 minutes after treatment administration
Title
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
Description
Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.
Time Frame
First 5 minutes after treatment administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Burton, M.D.
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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