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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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