Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT01265875
* 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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Lebanon, New Hampshire, 03756, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose Escalation
Other names: ChiRhoStim
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.
Time frame: Baseline, Day 4, Day 30.
Daily opiate use (oral morphine equivalent).
Time frame: Baseline, Day 4, Day 30.
Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Time frame: 30 Days
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.
ChiRhoClin, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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