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

Phase 2CompletedNCT00672074

Helsinn Therapeutics (U.S.), Inc117 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

117

Conditions

Ileus

Interventions

IpamorelinDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (19)

USC/Norris Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Recovery of GI function

Time frame: Until hospital discharge

Data from ClinicalTrials.gov

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