Clinical Trial: Secretin Infusion for Pain Due to Chronic Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Secretin Infusion for Pain Due to Chronic Pancreatitis

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.

Detailed Summary: 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.
Sponsor: ChiRhoClin, Inc.

Current Primary Outcome:

  • VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. [ Time Frame: 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.
  • Opiate Use at Baseline, Days 4 and 30. [ Time Frame: Baseline, Day 4, Day 30. ]
    Daily opiate use (oral morphine equivalent).
  • Quality of Life at Baseline, Day 4 and Day 30. [ Time Frame: Baseline, Day 4, Day 30. ]
    Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.


Original Primary Outcome: Improvement of Pain Control [ Time Frame: 30 Days ]

After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.


Current Secondary Outcome:

  • Number of Participants With Serious Adverse Events. [ Time Frame: 30 Days ]
  • VAS Score at Each Administered Dose. [ Time Frame: Days 1, 2, and 3. ]
    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.


Original Secondary Outcome: Safety of intravenous secretin administration at dosages higher then currently approved. [ Time Frame: 30 Days ]

Information By: ChiRhoClin, Inc.

Dates:
Date Received: December 22, 2010
Date Started: December 2010
Date Completion:
Last Updated: March 8, 2016
Last Verified: March 2016