Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
This study has been completed.
Sponsor:
Helsinn Therapeutics (U.S.), Inc
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
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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
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 May 21, 2013