Secretin Infusion for Pain Due to Chronic Pancreatitis
This study has been completed.
Sponsor:
ChiRhoClin, Inc.
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
ChiRhoClin, Inc.
ClinicalTrials.gov Identifier:
NCT01265875
First received: December 22, 2010
Last updated: February 11, 2013
Last verified: February 2013
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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 |
|---|---|---|
|
Pain Due to 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: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Secretin Infusion for Pain Due to Chronic Pancreatitis |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
Drug Information available for:
Human secretin
U.S. FDA Resources
Further study details as provided by ChiRhoClin, Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Safety of intravenous secretin administration at dosages higher then currently approved. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
| 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 |
Drug: Human Secretin
Dose Escalation
Other Name: ChiRhoStim
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
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
No publications provided
| Responsible Party: | ChiRhoClin, Inc. |
| ClinicalTrials.gov Identifier: | NCT01265875 History of Changes |
| Other Study ID Numbers: | 2010-01 |
| Study First Received: | December 22, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ChiRhoClin, Inc.:
|
Pain Chronic Pancreatitis Secretin |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatitis, Chronic Pancreatic Diseases Digestive System Diseases Secretin Gastrointestinal Agents |
Therapeutic Uses Pharmacologic Actions Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013