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

April 12, 2017 updated by: Helsinn Therapeutics (U.S.), Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Cancer Center
      • Palo Alto, California, United States, 94304
        • Palo Alto Veterans Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Denver, Colorado, United States, 80220
        • Denver VA Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic of Weston
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Healthcare
    • Michigan
      • Royal Oak, Michigan, United States, 48067
        • William Beaumont Hospital
    • Missouri
      • St. Louis, Missouri, United States, 38104
        • Barnes Jewish Hospital
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Pennsylvania State University
    • Washington
      • Tacoma, Washington, United States, 98405
        • St. Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2 Placebo
Drug: placebo
IV
Other Names:
  • ST
Active Comparator: 1 Ipamorelin
Drug: Ipamorelin
IV
Other Names:
  • ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery of GI function
Time Frame: Until hospital discharge
Until hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinn Therapeutics (U.S.), Inc

Investigators

  • Study Director: Suzan Allen, Helsinn Therapeutics (U.S.), Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-IPAM-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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