Secretin Infusion for Pain Due to Chronic Pancreatitis
|ClinicalTrials.gov Identifier: NCT01265875|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 1, 2016
Last Update Posted : March 9, 2016
- 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 or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis||Drug: Human Secretin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secretin Infusion for Pain Due to Chronic Pancreatitis|
|Study Start Date :||December 2010|
|Primary Completion Date :||December 2011|
|Study Completion Date :||April 2012|
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
Other Name: ChiRhoStim
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265875
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Timothy B Gardner, M.D.||Dartmouth-Hitchcock Medical Center|