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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ChiRhoClin, Inc.
ClinicalTrials.gov Identifier:
NCT01087801
First received: March 15, 2010
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Disease
 Drug: ChiRhoStim
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ChiRhoClin, Inc.:

Primary Outcome Measures:
  • Endoscopic Sample [ Time Frame: First 5 minutes after treatment administration ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.


Enrollment: 64
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ChiRhoStim
Human Secretin for Injection
 Drug: ChiRhoStim
Human Secretin for Injection
Placebo Comparator: Placebo
Saline for Injection
 Drug: Placebo
Saline for Injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087801

Locations
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
ChiRhoClin, Inc.
Investigators
Principal Investigator: Frank Burton, M.D. St. Louis University
  More Information

No publications provided

Responsible Party: ChiRhoClin, Inc.
ClinicalTrials.gov Identifier: NCT01087801     History of Changes
Other Study ID Numbers: 2006-05
Study First Received: March 15, 2010
Results First Received: June 7, 2011
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ChiRhoClin, Inc.:
Genetic End Marker

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Secretin
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013