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
Phase 2
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Ileus
Both
Ileus
Trial Information
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
The safety and efficacy of ipamorelin in the management of post-operative ileus
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
Type of Study:
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
Outcome Measure:
Recovery of GI function
Outcome Time Frame:
Until hospital discharge
Safety Issue:
No
Principal Investigator
Suzan Allen
Investigator Role:
Study Director
Investigator Affiliation:
Helsinn Therapeutics (U.S.), Inc
Authority:
United States: Food and Drug Administration
Study ID:
ST-IPAM-201
NCT ID:
NCT00672074
Start Date:
April 2008
Completion Date:
December 2009
Related Keywords:
- Ileus
- Postoperative Ileus
- Ileus
Name | Location |
|---|---|
| Cedars Sinai Medical Center | Los Angeles, California 90048-1804 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Washington Hospital Center | Washington, District of Columbia 20010 |
| University of Colorado Hospital | Denver, Colorado 80262 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
| USC/Norris Cancer Center | Los Angeles, California |
| Barnes Jewish Hospital | St. Louis, Missouri 63110 |
| Stony Brook University Medical Center | Stony Brook, New York 11794 |
| University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
| The Christ Hospital | Cincinnati, Ohio 45219 |
| Palo Alto Veterans Hospital | Palo Alto, California 94304 |
| Denver VA Hospital | Denver, Colorado 80220 |
| Cleveland Clinic of Weston | Weston, Florida 33331 |
| St. Joseph's Hospital of Atlanta | Atlanta, Georgia 30342 |
| Ochsner Medical Center | New Orleans, Louisiana 70121 |
| UMass Memorial Healthcare | Worcester, Massachusetts 01605 |
| The Pennsylvania State University | Hershey, Pennsylvania 17033 |
| St. Joseph Hospital | Tacoma, Washington 98405 |
