DRUG
ChiRhoStim
Human Secretin for Injection
Status
Completed
Phase
Phase 3
Enrollment
64
Locations
1
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
Human Secretin for Injection
DRUG
Saline for Injection
Timeline
First posted
Mar 16, 2010
Study start
Oct 2007
Primary completion
Nov 2009
Study completion
Dec 2009
Results posted
Dec 2, 2011
Registry updated
Dec 6, 2011
Outcomes
Endoscopic Sample
Time frame · 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).
Time frame · First 5 minutes after treatment administration
Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.
Not reported in the indexed record.
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Saint Louis University
St Louis, Missouri, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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