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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672074
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ileus Drug: Ipamorelin Drug: placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: 1 Ipamorelin Drug: Ipamorelin
Other Name: ST

Placebo Comparator: 2 Placebo Drug: placebo
Other Name: ST

Primary Outcome Measures :
  1. Recovery of GI function [ Time Frame: Until hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672074

United States, California
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Palo Alto Veterans Hospital
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Denver VA Hospital
Denver, Colorado, United States, 80220
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Cleveland Clinic of Weston
Weston, Florida, United States, 33331
United States, Georgia
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
UMass Memorial Healthcare
Worcester, Massachusetts, United States, 01605
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48067
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 38104
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
The Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
United States, Washington
St. Joseph Hospital
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Study Director: Suzan Allen Helsinn Therapeutics (U.S.), Inc

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helsinn Therapeutics (U.S.), Inc Identifier: NCT00672074     History of Changes
Other Study ID Numbers: ST-IPAM-201
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Helsinn Therapeutics (U.S.), Inc:
Postoperative Ileus

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases