Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
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
1 other identifier
interventional
117
1 country
19
Brief Summary
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 14, 2017
April 1, 2017
1.7 years
May 2, 2008
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery of GI function
Until hospital discharge
Study Arms (2)
1 Ipamorelin
ACTIVE COMPARATOR2 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- willing to comply with protocol
- undergoing bowel resection surgery
- ASA Class I-III
- Females must not be pregnant
- Body weight 40-150 kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
USC/Norris Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Palo Alto Veterans Hospital
Palo Alto, California, 94304, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver VA Hospital
Denver, Colorado, 80220, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Cleveland Clinic of Weston
Weston, Florida, 33331, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
UMass Memorial Healthcare
Worcester, Massachusetts, 01605, United States
William Beaumont Hospital
Royal Oak, Michigan, 48067, United States
Barnes Jewish Hospital
St Louis, Missouri, 38104, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
St. Joseph Hospital
Tacoma, Washington, 98405, United States
Related Publications (1)
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.
PMID: 25331030DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Suzan Allen
Helsinn Therapeutics (U.S.), Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 14, 2017
Record last verified: 2017-04