Skip to main content
OpenTrials
Completed

NCT Number: NCT00672074

Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ileus Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

About this study

The safety and efficacy of ipamorelin in the management of post-operative ileus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • willing to comply with protocol
  • undergoing bowel resection surgery
  • ASA Class I-III
  • Females must not be pregnant
  • Body weight 40-150 kg

Exclusion criteria

  • mentally incompetent or unable to provide informed consent
  • clinically unstable
  • significant liver disease
  • clinically significant lab or EKG abnormalities
  • alcohol or illicit drug abuse
  • history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

Treatment and study plan

Ipamorelin

Drug

IV

Other names: ST

Placebo

Drug

IV

Other names: ST

Primary outcomes

  1. Recovery of GI function

    Time frame: Until hospital discharge

Sponsors and collaborators

Lead sponsor

Helsinn Therapeutics (U.S.), Inc

Industry

Registry information

Official study title

A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 6, 2008
Registry last updated
Apr 14, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.