当前位置： SCI文献检索 > INTERNATIONAL JOURNAL OF COLORECTAL DISEASE期刊下所有文献 > Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.

Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.

Abstract：

BACKGROUND:Postoperative ileus is a significant clinical challenge lacking effective management strategies. Ghrelin-receptor stimulation has promotility effects in the upper and lower gastrointestinal tract. OBJECTIVE:This proof-of-concept, phase 2, randomized study evaluated the safety and efficacy of the ghrelin-receptor agonist ipamorelin in the treatment of postoperative ileus following abdominal surgery (ClinicalTrials.gov NCT00672074). DESIGN:The design was a multicenter, double-blind, placebo-controlled, clinical trial. SETTINGS:The settings include hospital inpatients. PATIENTS:The patients were adults undergoing small and large bowel resection by open or laparoscopic surgery. INTERVENTION:The intervention was intravenous infusions of 0.03-mg/kg ipamorelin vs placebo twice daily, on postoperative day 1 to 7 or hospital discharge. MAIN OUTCOME MEASURES:Safety was assessed by monitoring adverse events and laboratory tests. The key efficacy endpoint was time from first dose of study drug to tolerance of a standardized solid meal. RESULTS:One hundred seventeen patients were enrolled, of whom 114 patients composed the safety and modified intent-to-treat populations. Demographic and disease characteristics were balanced between groups. Overall incidence of any treatment-emergent adverse events was 87.5 % in the ipamorelin group and 94.8 % in placebo group. Median time to first tolerated meal was 25.3 and 32.6 h in the ipamorelin and placebo groups, respectively (p = 0.15). LIMITATIONS:This proof of concept study was small and enrolled patients with a broad range of underlying conditions. CONCLUSIONS:Ipamorelin 0.03-mg/kg twice daily for up to 7 days was well tolerated. There were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.

journal_name

Int J Colorectal Dis

journal_title

International journal of colorectal disease

authors

Beck DE,Sweeney WB,McCarter MD,Ipamorelin 201 Study Group.

doi

10.1007/s00384-014-2030-8

subject

Has Abstract

pub_date

2014-12-01 00:00:00

pages

1527-34

issue

eissn

0179-1958

issn

1432-1262

journal_volume

pub_type

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Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.