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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
Not Enrolling
Both
Ileus

Thank you

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