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NCT00672074 Clinical Trial

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

Ileus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00672074
Other study ID # ST-IPAM-201
Secondary ID
Status Completed
Phase Phase 2
First received May 2, 2008
Last updated April 12, 2017
Start date April 2008
Est. completion date December 2009

Study information
Verified date April 2017
Source Helsinn Therapeutics (U.S.), Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

The safety and efficacy of ipamorelin in the management of post-operative ileus

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ipamorelin
IV
• placebo
IV

Locations
Country Name City State
United States St. Joseph's Hospital of Atlanta Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States University of Illinois at Chicago Chicago Illinois
United States The Christ Hospital Cincinnati Ohio
United States University Hospitals Case Medical Center Cleveland Ohio
United States Denver VA Hospital Denver Colorado
United States The Pennsylvania State University Hershey Pennsylvania
United States Indiana University Medical Center Indianapolis Indiana
United States Cedars Sinai Medical Center Los Angeles California
United States USC/Norris Cancer Center Los Angeles California
United States Ochsner Medical Center New Orleans Louisiana
United States Palo Alto Veterans Hospital Palo Alto California
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 St. Joseph Hospital Tacoma Washington
United States Washington Hospital Center Washington District of Columbia
United States Cleveland Clinic of Weston Weston Florida
United States UMass Memorial Healthcare Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recovery of GI function Until hospital discharge
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