Phase 3
Completed N=64
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
Source: ClinicalTrials.gov NCT01087801 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Endoscopic Sample
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopic Sample |
— | — |
| PRIMARY Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). |
25; 2; 1; 27 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01087801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.