Clinical trial NCT00672074: Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ileus
Keywords: Postoperative Ileus
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Recovery of GI function
timeFrame: Until hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Veterans Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver VA Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic of Weston
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Worcester
country: United States
facility: UMass Memorial Healthcare
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Hershey
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Tacoma
country: United States
facility: St. Joseph Hospital
state: Washington
Study officials:
affiliation: Helsinn Therapeutics (U.S.), Inc
name: Suzan Allen
role: STUDY_DIRECTOR
References:
citation: Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. doi: 10.1007/s00384-014-2030-8. Epub 2014 Oct 21.