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

Beck, David E., Sweeney, W. Brian and McCarter, Martin D. (2014) Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. International Journal of Colorectal Disease, 29 12: 1527-1534. doi:10.1007/s00384-014-2030-8


Author Beck, David E.
Sweeney, W. Brian
McCarter, Martin D.
Title Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients
Journal name International Journal of Colorectal Disease   Check publisher's open access policy
ISSN 1432-1262
0179-1958
Publication date 2014-12
Year available 2014
Sub-type Article (original research)
DOI 10.1007/s00384-014-2030-8
Open Access Status
Volume 29
Issue 12
Start page 1527
End page 1534
Total pages 8
Place of publication Heidelberg Germany
Publisher Springer
Collection year 2015
Language eng
Formatted 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.
Keyword Abdominal surgery
Ghrelin-receptor agonist
Gastrointestinal
Ileus
Medication
Postoperative management
Prokinetic
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Medicine Publications
 
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