Secretin Infusion for Pain Due to Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

Secretin Infusion for Pain Due to Chronic Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265875
• Other study ID #: 2010-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 22, 2010
• Last updated: March 8, 2016
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2016
• Source: ChiRhoClin, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Human Secretin
Dose Escalation

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
ChiRhoClin, Inc.	Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Opiate Use at Baseline, Days 4 and 30.	Daily opiate use (oral morphine equivalent).	Baseline, Day 4, Day 30.	No
Primary	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.	No
Secondary	Number of Participants With Serious Adverse Events.		30 Days	Yes
Secondary	VAS Score at Each Administered Dose.	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.	Days 1, 2, and 3.	No