A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis

John Levenick, Catherine L. Andrews, Edward D. Purich, Stuart R. Gordon, Timothy B. Gardner

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

OBJECTIVE: We aimed to determine if intravenous synthetic human secretin (sHS) improves refractory type B pain in patients with chronic pancreatitis (CP). METHODS: In a phase II dose escalation trial, patients with CP received sHS of varying doses (0.05-0.8 μg/kg) for 3 days. The primary outcomes were changes in the visual analogue pain score (VAS), short form (SF) - 36, and opiate use from baseline at 30 days after infusion. RESULTS: Twelve patients (mean age, 42 years, 6 men) were included. Mean pain scores (VAS) were 5.79, 4.80, 4.72, and 4.90, at baseline, day 4, day 10, and day 30, respectively (P = 0.25, 0.19, and 0.27 when compared with baseline, respectively). Daily opiate use (oral morphine equivalents) decreased throughout the study from a baseline value of 136 to 111 mg on day 4 (P = 0.52) and to 104 mg on day 30 (P = 0.34). In subgroup analysis, women had the most improvement (VAS baseline, 5.42 vs VAS day 30, 3.67; P = 0.07; baseline morphine equivalents, 107 mg vs. 84 mg; P = 0.21). CONCLUSIONS: In patients, especially women, with refractory type B pain from CP, intravenous sHS administration demonstrated a trend toward improvement in self-reported pain and opiate use at 30 days after infusion, although statistical significance was not achieved (clinicaltrials.gov registration number NCT01265875).

Original languageEnglish (US)
Pages (from-to)596-600
Number of pages5
JournalPancreas
Volume42
Issue number4
DOIs
StatePublished - May 1 2013

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Intractable Pain
Secretin
Chronic Pancreatitis
Opiate Alkaloids
Pain
Morphine

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Hepatology
  • Endocrinology

Cite this

Levenick, John ; Andrews, Catherine L. ; Purich, Edward D. ; Gordon, Stuart R. ; Gardner, Timothy B. / A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. In: Pancreas. 2013 ; Vol. 42, No. 4. pp. 596-600.
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abstract = "OBJECTIVE: We aimed to determine if intravenous synthetic human secretin (sHS) improves refractory type B pain in patients with chronic pancreatitis (CP). METHODS: In a phase II dose escalation trial, patients with CP received sHS of varying doses (0.05-0.8 μg/kg) for 3 days. The primary outcomes were changes in the visual analogue pain score (VAS), short form (SF) - 36, and opiate use from baseline at 30 days after infusion. RESULTS: Twelve patients (mean age, 42 years, 6 men) were included. Mean pain scores (VAS) were 5.79, 4.80, 4.72, and 4.90, at baseline, day 4, day 10, and day 30, respectively (P = 0.25, 0.19, and 0.27 when compared with baseline, respectively). Daily opiate use (oral morphine equivalents) decreased throughout the study from a baseline value of 136 to 111 mg on day 4 (P = 0.52) and to 104 mg on day 30 (P = 0.34). In subgroup analysis, women had the most improvement (VAS baseline, 5.42 vs VAS day 30, 3.67; P = 0.07; baseline morphine equivalents, 107 mg vs. 84 mg; P = 0.21). CONCLUSIONS: In patients, especially women, with refractory type B pain from CP, intravenous sHS administration demonstrated a trend toward improvement in self-reported pain and opiate use at 30 days after infusion, although statistical significance was not achieved (clinicaltrials.gov registration number NCT01265875).",
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A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. / Levenick, John; Andrews, Catherine L.; Purich, Edward D.; Gordon, Stuart R.; Gardner, Timothy B.

In: Pancreas, Vol. 42, No. 4, 01.05.2013, p. 596-600.

Research output: Contribution to journalArticle

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AU - Levenick, John

AU - Andrews, Catherine L.

AU - Purich, Edward D.

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AU - Gardner, Timothy B.

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N2 - OBJECTIVE: We aimed to determine if intravenous synthetic human secretin (sHS) improves refractory type B pain in patients with chronic pancreatitis (CP). METHODS: In a phase II dose escalation trial, patients with CP received sHS of varying doses (0.05-0.8 μg/kg) for 3 days. The primary outcomes were changes in the visual analogue pain score (VAS), short form (SF) - 36, and opiate use from baseline at 30 days after infusion. RESULTS: Twelve patients (mean age, 42 years, 6 men) were included. Mean pain scores (VAS) were 5.79, 4.80, 4.72, and 4.90, at baseline, day 4, day 10, and day 30, respectively (P = 0.25, 0.19, and 0.27 when compared with baseline, respectively). Daily opiate use (oral morphine equivalents) decreased throughout the study from a baseline value of 136 to 111 mg on day 4 (P = 0.52) and to 104 mg on day 30 (P = 0.34). In subgroup analysis, women had the most improvement (VAS baseline, 5.42 vs VAS day 30, 3.67; P = 0.07; baseline morphine equivalents, 107 mg vs. 84 mg; P = 0.21). CONCLUSIONS: In patients, especially women, with refractory type B pain from CP, intravenous sHS administration demonstrated a trend toward improvement in self-reported pain and opiate use at 30 days after infusion, although statistical significance was not achieved (clinicaltrials.gov registration number NCT01265875).

AB - OBJECTIVE: We aimed to determine if intravenous synthetic human secretin (sHS) improves refractory type B pain in patients with chronic pancreatitis (CP). METHODS: In a phase II dose escalation trial, patients with CP received sHS of varying doses (0.05-0.8 μg/kg) for 3 days. The primary outcomes were changes in the visual analogue pain score (VAS), short form (SF) - 36, and opiate use from baseline at 30 days after infusion. RESULTS: Twelve patients (mean age, 42 years, 6 men) were included. Mean pain scores (VAS) were 5.79, 4.80, 4.72, and 4.90, at baseline, day 4, day 10, and day 30, respectively (P = 0.25, 0.19, and 0.27 when compared with baseline, respectively). Daily opiate use (oral morphine equivalents) decreased throughout the study from a baseline value of 136 to 111 mg on day 4 (P = 0.52) and to 104 mg on day 30 (P = 0.34). In subgroup analysis, women had the most improvement (VAS baseline, 5.42 vs VAS day 30, 3.67; P = 0.07; baseline morphine equivalents, 107 mg vs. 84 mg; P = 0.21). CONCLUSIONS: In patients, especially women, with refractory type B pain from CP, intravenous sHS administration demonstrated a trend toward improvement in self-reported pain and opiate use at 30 days after infusion, although statistical significance was not achieved (clinicaltrials.gov registration number NCT01265875).

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