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Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00672074
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc

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

Condition or disease Intervention/treatment Phase
Ileus Drug: Ipamorelin Drug: placebo Phase 2

Detailed Description:
The safety and efficacy of ipamorelin in the management of post-operative ileus
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Ipamorelin Drug: Ipamorelin
IV
Other Name: ST
Placebo Comparator: 2 Placebo Drug: placebo
IV
Other Name: ST


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of GI function [ Time Frame: Until hospital discharge ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672074


Locations
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Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
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Study Director: Suzan Allen Helsinn Therapeutics (U.S.), Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT00672074    
Other Study ID Numbers: ST-IPAM-201
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Keywords provided by Helsinn Therapeutics (U.S.), Inc:
Postoperative Ileus
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases