Secretin Infusion for Pain Due to Chronic Pancreatitis

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Brief Title

Secretin Infusion for Pain Due to Chronic Pancreatitis

Official Title

Secretin Infusion for Pain Due to Chronic Pancreatitis

Brief Summary

      -  To determine if intravenous secretin administration in escalating doses three times
           daily for three days will improve the pain from CP at the time of infusion, after each
           infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.

        -  To validate the safety of intravenous secretin administration at the dosage indicated in
           this study.
    

Detailed Description

      12 patients will be enrolled in this study. Patients will be only those treated at
      Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made
      by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must
      be taking prescribed opioid analgesics for the specific treatment of CP at the time of study
      enrollment. Only patients between the ages of 18-70 and capable of providing informed consent
      will be considered eligible for the study.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.

Secondary Outcome

 Number of Participants With Serious Adverse Events.

Condition

Chronic Pancreatitis

Intervention

Human Secretin

Study Arms / Comparison Groups

 human secretin
Description:  intravenous secretin administration in escalating doses three times daily for three days. After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

December 2010

Completion Date

April 2012

Primary Completion Date

December 2011

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female, between the ages of 18-70 years old.

          2. Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP
             and/or pancreatic function tests.

          3. If female, and not more than 1 year post-menopausal or surgically sterile, must use
             medically acceptable form of contraception or abstain from sexual activity during the
             study. Acceptable methods of birth control are: intrauterine device, implantable
             progesterone device, progesterone intramuscular injection, oral contraceptive (started
             at least one month prior to Screening Visit 1 and continuing for the duration of the
             trial), contraceptive patch, condoms with spermicide or abstinence.

          4. If a female of reproductive potential, receive counseling on pregnancy protection and
             effective contraception within 30 days prior to dosing with secretin.

          5. Negative serum pregnancy within 72 hours of secretin administration.

          6. Use of opioid analgesics for chronic pain from CP.

          7. Willing and able to sign written informed consent.

        Exclusion Criteria:

          1. Male or female <18 or >70 years of age.

          2. Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days
             of study enrollment.

          3. Exhibiting signs and/or symptoms of an episode of acute pancreatitis.

          4. Severe cardiac disease (stable or unstable angina, congestive heart failure,
             uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).

          5. Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).

          6. Severe renal disease (history of acute or chronic renal failure, dialysis dependent,
             baseline creatinine >2.0 mg/dL).

          7. Previous adverse drug event to intravenous secretin.

          8. Ongoing illicit drug use or abuse.

          9. Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine
             and/or 1 oz liquor /day.

         10. Acute pancreatitis as defined by the Atlanta Classification definition (refer to Table
             1) within the previous two months or symptoms consistent with ongoing acute
             pancreatitis.

         11. Prior pancreatic surgery.

         12. Pregnant women, nursing mothers, or women of childbearing potential not employing
             appropriate contraception.

         13. Use of medication that can potentially cause pancreatitis, such as metronidazole,
             tetracycline, sulfonamides within 30 days prior to Visit 1.

         14. Any medical condition which, in the judgment of the investigator, renders
             participation in this study medically inadvisable.

         15. Participation in an investigational clinical study for a drug or medical device within
             30 days prior to Visit 1.

         16. Unwilling or unable to give written, informed consent.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Timothy B Gardner, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01265875

Organization ID

2010-01


Responsible Party

Sponsor

Study Sponsor

ChiRhoClin, Inc.

Collaborators

 Dartmouth-Hitchcock Medical Center

Study Sponsor

Timothy B Gardner, M.D., Principal Investigator, Dartmouth-Hitchcock Medical Center


Verification Date

March 2016