Secretin Infusion for Pain Due to Chronic Pancreatitis

NCT01265875 | Completed Phase 1 Results DMC

• 1 other identifier: 2010-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (3)

• VAS Score at 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.

  Baseline, Days 1, 2, 3, 4, 7, 30.

• Opiate Use at Baseline, Days 4 and 30.

  Daily opiate use (oral morphine equivalent).

  Baseline, Day 4, Day 30.

• Quality of Life at Baseline, Day 4 and Day 30.

  Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.

  Baseline, Day 4, Day 30.

Secondary Outcomes (2)

• Number of Participants With Serious Adverse Events.

  30 Days

• VAS Score at Each Administered Dose.

  Days 1, 2, and 3.

Study Arms (1)

human secretin

OTHER

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

Interventions

Human Secretin DRUG

Dose Escalation

Also known as: ChiRhoStim

human secretin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between the ages of 18-70 years old.
• Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.
• 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.
• If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.
• Negative serum pregnancy within 72 hours of secretin administration.
• Use of opioid analgesics for chronic pain from CP.
• Willing and able to sign written informed consent.

You may not qualify if:

• Male or female \<18 or \>70 years of age.
• Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.
• Exhibiting signs and/or symptoms of an episode of acute pancreatitis.
• Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
• Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
• Severe renal disease (history of acute or chronic renal failure, dialysis dependent, baseline creatinine \>2.0 mg/dL).
• Previous adverse drug event to intravenous secretin.
• Ongoing illicit drug use or abuse.
• Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine and/or 1 oz liquor /day.
• 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.
• Prior pancreatic surgery.
• Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.
• Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.
• Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.
• Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.

Sponsors & Collaborators

• ChiRhoClin, Inc.: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 23548879 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Timothy Gardner, MD
• Organization: Dartmouth-Hitchcock Medical Center

timothy.b.gardner@hitchcock.org

603-650-6472

Study Officials

• Timothy B Gardner, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 9, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-03

Locations

US (1)