Current partner codePEPTIDESDE
NCT01087801·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

64

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

ChiRhoStim

Human Secretin for Injection

DRUG

Placebo

Saline for Injection

Timeline

From registration to results.

  1. First posted

    Mar 16, 2010

  2. Study start

    Oct 2007

  3. Primary completion

    Nov 2009

  4. Study completion

    Dec 2009

  5. Results posted

    Dec 2, 2011

  6. Registry updated

    Dec 6, 2011

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Saint Louis University

St Louis, Missouri, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.