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

A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00672074

Enrollment

117

Registered

2008-05-06

Start date

2008-04-30

Completion date

2009-12-31

Last updated

2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileus

Keywords

Postoperative Ileus

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

Interventions

DRUGIpamorelin

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recovery of GI function	Until hospital discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026