Status:
COMPLETED
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Lead Sponsor:
Helsinn Therapeutics (U.S.), Inc
Conditions:
Ileus
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- willing to comply with protocol
- undergoing bowel resection surgery
- ASA Class I-III
- Females must not be pregnant
- Body weight 40-150 kg
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00672074
Start Date
April 1 2008
End Date
December 1 2009
Last Update
April 14 2017
Active Locations (19)
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1
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Palo Alto Veterans Hospital
Palo Alto, California, United States, 94304
4
University of Colorado Hospital
Aurora, Colorado, United States, 80045