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

Phase 2

Completed

• Conditions: Ileus
• Interventions: Drug: placebo; Drug: Ipamorelin

• Registration Number: NCT00672074
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc

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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Disposition First Posted: 2011-06-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 Placebo	placebo	-
1 Ipamorelin	Ipamorelin	-

Primary Outcome Measures

Name	Time	Method
Recovery of GI function	Until hospital discharge

Trial Locations

Locations (19)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

USC/Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

Palo Alto Veterans Hospital; 🇺🇸 Palo Alto, California, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Denver VA Hospital; 🇺🇸 Denver, Colorado, United States

St. Joseph's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Cleveland Clinic of Weston; 🇺🇸 Weston, Florida, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, 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

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

St. Joseph Hospital; 🇺🇸 Tacoma, Washington, United States

The Pennsylvania State University; 🇺🇸 Hershey, Pennsylvania, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States