Status:
COMPLETED
Secretin Infusion for Pain Due to Chronic Pancreatitis
Lead Sponsor:
ChiRhoClin, Inc.
Collaborating Sponsors:
Dartmouth-Hitchcock Medical Center
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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...
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 stand...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Unwilling or unable to give written, informed consent.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01265875
Start Date
December 1 2010
End Date
April 1 2012
Last Update
March 9 2016
Active Locations (1)
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1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756