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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 (CRC2006-05)

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ClinicalTrials.gov Identifier: NCT01087801
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : December 2, 2011
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
ChiRhoClin, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Disease Drug: ChiRhoStim Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
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 Start Date : October 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ChiRhoStim
Human Secretin for Injection
 Drug: ChiRhoStim
Human Secretin for Injection
Placebo Comparator: Placebo
Saline for Injection
 Drug: Placebo
Saline for Injection


Outcome Measures
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Primary Outcome Measures :
  1. 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).


  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087801


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
ChiRhoClin, Inc.
Investigators
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Principal Investigator: Frank Burton, M.D. St. Louis University
More Information
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Responsible Party: ChiRhoClin, Inc.
ClinicalTrials.gov Identifier: NCT01087801    
Other Study ID Numbers: 2006-05
First Posted: March 16, 2010    Key Record Dates
Results First Posted: December 2, 2011
Last Update Posted: December 6, 2011
Last Verified: December 2011
Keywords provided by ChiRhoClin, Inc.:
Genetic End Marker
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases