Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
NCT ID: NCT00672074
Last Updated: 2017-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2008-04-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1 Ipamorelin
Ipamorelin
IV
2 Placebo
placebo
IV
Interventions
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Ipamorelin
IV
placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing bowel resection surgery
* ASA Class I-III
* Females must not be pregnant
* Body weight 40-150 kg
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Helsinn Therapeutics (U.S.), Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Suzan Allen
Role: STUDY_DIRECTOR
Helsinn Therapeutics (U.S.), Inc
Locations
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USC/Norris Cancer Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Palo Alto Veterans Hospital
Palo Alto, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver VA Hospital
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Cleveland Clinic of Weston
Weston, Florida, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
UMass Memorial Healthcare
Worcester, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
St. Joseph Hospital
Tacoma, Washington, United States
Countries
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References
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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.
Other Identifiers
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ST-IPAM-201
Identifier Type: -
Identifier Source: org_study_id
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