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Secretin Infusion for Pain Due to Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265875
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 1, 2016
Last Update Posted : March 9, 2016
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
ChiRhoClin, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Human Secretin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Secretin Infusion for Pain Due to Chronic Pancreatitis
Study Start Date : December 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
human secretin
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.
Drug: Human Secretin
Dose Escalation
Other Name: ChiRhoStim

Primary Outcome Measures :
  1. VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. [ Time Frame: Baseline, Days 1, 2, 3, 4, 7, 30. ]
    10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.

  2. Opiate Use at Baseline, Days 4 and 30. [ Time Frame: Baseline, Day 4, Day 30. ]
    Daily opiate use (oral morphine equivalent).

  3. Quality of Life at Baseline, Day 4 and Day 30. [ Time Frame: Baseline, Day 4, Day 30. ]
    Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.

Secondary Outcome Measures :
  1. Number of Participants With Serious Adverse Events. [ Time Frame: 30 Days ]
  2. VAS Score at Each Administered Dose. [ Time Frame: Days 1, 2, and 3. ]
    10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01265875

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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
ChiRhoClin, Inc.
Dartmouth-Hitchcock Medical Center
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Principal Investigator: Timothy B Gardner, M.D. Dartmouth-Hitchcock Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ChiRhoClin, Inc. Identifier: NCT01265875     History of Changes
Other Study ID Numbers: 2010-01
First Posted: December 23, 2010    Key Record Dates
Results First Posted: March 1, 2016
Last Update Posted: March 9, 2016
Last Verified: March 2016
Keywords provided by ChiRhoClin, Inc.:
Chronic Pancreatitis
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs