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

Primary Purpose

Ileus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ipamorelin
placebo
Sponsored by
Helsinn Therapeutics (U.S.), Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileus focused on measuring Postoperative Ileus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Cancer Center
  • Cedars Sinai Medical Center
  • Palo Alto Veterans Hospital
  • University of Colorado Hospital
  • Denver VA Hospital
  • Washington Hospital Center
  • Cleveland Clinic of Weston
  • St. Joseph's Hospital of Atlanta
  • University of Illinois at Chicago
  • Indiana University Medical Center
  • Ochsner Medical Center
  • UMass Memorial Healthcare
  • William Beaumont Hospital
  • Barnes Jewish Hospital
  • Stony Brook University Medical Center
  • The Christ Hospital
  • University Hospitals Case Medical Center
  • The Pennsylvania State University
  • St. Joseph Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 Ipamorelin

2 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Recovery of GI function

Secondary Outcome Measures

Full Information

First Posted
May 2, 2008
Last Updated
April 12, 2017
Sponsor
Helsinn Therapeutics (U.S.), Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00672074
Brief Title
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Therapeutics (U.S.), Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
Detailed Description
The safety and efficacy of ipamorelin in the management of post-operative ileus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Ipamorelin
Arm Type
Active Comparator
Arm Title
2 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ipamorelin
Other Intervention Name(s)
ST
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
ST
Intervention Description
IV
Primary Outcome Measure Information:
Title
Recovery of GI function
Time Frame
Until hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Allen
Organizational Affiliation
Helsinn Therapeutics (U.S.), Inc
Official's Role
Study Director
Facility Information:
Facility Name
USC/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Palo Alto Veterans Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver VA Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cleveland Clinic of Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
St. Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
UMass Memorial Healthcare
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
38104
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
St. Joseph Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25331030
Citation
Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.
Results Reference
derived

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

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