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Secretin Infusion for Pain Due to Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
ChiRhoClin, Inc.
ClinicalTrials.gov Identifier:
NCT01265875
First received: December 22, 2010
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
  • 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 Intervention Phase
Chronic Pancreatitis
Drug: Human Secretin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Secretin Infusion for Pain Due to Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by ChiRhoClin, Inc.:

Primary Outcome Measures:
  • VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. [ Time Frame: Baseline, Days 1, 2, 3, 4, 7, 30. ] [ Designated as safety issue: No ]
    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.

  • Opiate Use at Baseline, Days 4 and 30. [ Time Frame: Baseline, Day 4, Day 30. ] [ Designated as safety issue: No ]
    Daily opiate use (oral morphine equivalent).

  • Quality of Life at Baseline, Day 4 and Day 30. [ Time Frame: Baseline, Day 4, Day 30. ] [ Designated as safety issue: No ]
    Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.


Secondary Outcome Measures:
  • Number of Participants With Serious Adverse Events. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • VAS Score at Each Administered Dose. [ Time Frame: Days 1, 2, and 3. ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265875

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ChiRhoClin, Inc.
ClinicalTrials.gov Identifier: NCT01265875     History of Changes
Other Study ID Numbers: 2010-01 
Study First Received: December 22, 2010
Results First Received: July 29, 2013
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by ChiRhoClin, Inc.:
Chronic Pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016