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

This study has been completed.
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00672074
First received: May 2, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Ileus
Drug: Ipamorelin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Helsinn Therapeutics (U.S.), Inc:

Primary Outcome Measures:
  • Recovery of GI function [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Ipamorelin Drug: Ipamorelin
IV
Other Name: ST
Placebo Comparator: 2 Placebo Drug: placebo
IV
Other Name: ST

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672074

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
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
Investigators
Study Director: Suzan Allen Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

Responsible Party: Suzan Allen, Helsinn Therapeutics (U.S.), Inc.
ClinicalTrials.gov Identifier: NCT00672074     History of Changes
Other Study ID Numbers: ST-IPAM-201
Study First Received: May 2, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014