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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

December 22, 2010
March 8, 2016
December 2010
December 2011   (final data collection date for primary outcome measure)
  • 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.
Improvement of Pain Control [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.
Complete list of historical versions of study NCT01265875 on ClinicalTrials.gov Archive Site
  • 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.
Safety of intravenous secretin administration at dosages higher then currently approved. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Secretin Infusion for Pain Due to Chronic Pancreatitis
Secretin Infusion for Pain Due to Chronic Pancreatitis
  • 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.
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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Pancreatitis
Drug: Human Secretin
Dose Escalation
Other Name: ChiRhoStim
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.
Intervention: Drug: Human Secretin
Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec. Erratum in: Pancreas. 2016 May-Jun;45(5):e23. Dosage error in article text.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01265875
2010-01
Yes
Not Provided
Not Provided
ChiRhoClin, Inc.
ChiRhoClin, Inc.
Dartmouth-Hitchcock Medical Center
Principal Investigator: Timothy B Gardner, M.D. Dartmouth-Hitchcock Medical Center
ChiRhoClin, Inc.
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP