Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Registered Phase 2 interventional trial (completed). The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
Registered clinical trial record on ClinicalTrials.gov (NCT00672074). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: completed. Study type: interventional. Phase: Phase 2. Sponsor: Helsinn Therapeutics (U.S.), Inc. Conditions: Ileus. Interventions: Ipamorelin, placebo. Summary: The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus. The safety and efficacy of ipamorelin in the management of post-operative ileus Primary outcome measures: Recovery of GI function. Eligibility: 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
Educational summary of published research — not medical advice. License: public-domain. Full text is shown only where licensing permits.