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

This study is currently recruiting participants.

Verified by Sapphire Therapeutics, Inc., June 2008

Sponsored by:	Sapphire Therapeutics, Inc.
Information provided by:	Sapphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00672074

Purpose

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

Condition	Intervention	Phase
Ileus	Drug: Ipamorelin Drug: placebo	Phase II

Drug Information available for: Ipamorelin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sapphire Therapeutics, Inc.:

Primary Outcome Measures:

Recovery of GI function [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	114
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Ipamorelin: Active Comparator	Drug: Ipamorelin IV
2 Placebo: Placebo Comparator	Drug: placebo IV

Detailed Description:

The sfaety and efficacy of ipamorelin in the management of post-operative ileus

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

mentally incompetant 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672074

Contacts

Contact: Suzan Allen, MS	908-203-6551	sallen@sapphirethera.com
Contact: Richard Nelson, PhD	908-203-6543	rnelson@sapphirethera.com

Locations

United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States
Principal Investigator: Harry Wasvary, MD

Sponsors and Collaborators

Sapphire Therapeutics, Inc.

More Information

Responsible Party:	Sapphire Therapeutics, Inc. ( Brenda Marczi, PharmD )
Study ID Numbers:	ST-IPAM-201
Study First Received:	May 2, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00672074
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sapphire Therapeutics, Inc.:

Postoperative Ileus

Study placed in the following topic categories:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009