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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 CenterLos Angeles, California  90048-1804
William Beaumont HospitalRoyal Oak, Michigan  48073
University of Illinois at ChicagoChicago, Illinois  60612
Washington Hospital CenterWashington, District of Columbia  20010
University of Colorado HospitalDenver, Colorado  80262
Indiana University Medical CenterIndianapolis, Indiana  46202
USC/Norris Cancer CenterLos Angeles, California  
Barnes Jewish HospitalSt. Louis, Missouri  63110
Stony Brook University Medical CenterStony Brook, New York  11794
University Hospitals Case Medical CenterCleveland, Ohio  44106
The Christ HospitalCincinnati, Ohio  45219
Palo Alto Veterans HospitalPalo Alto, California  94304
Denver VA HospitalDenver, Colorado  80220
Cleveland Clinic of WestonWeston, Florida  33331
St. Joseph's Hospital of AtlantaAtlanta, Georgia  30342
Ochsner Medical CenterNew Orleans, Louisiana  70121
UMass Memorial HealthcareWorcester, Massachusetts  01605
The Pennsylvania State UniversityHershey, Pennsylvania  17033
St. Joseph HospitalTacoma, Washington  98405