Ulimorelin Study of Efficacy and Safety (ULISES 008)

This study has been completed.

Sponsor:

Collaborator:

Norgine

Information provided by (Responsible Party):

Tranzyme, Inc.

ClinicalTrials.gov Identifier:

NCT01296620

First received: February 14, 2011

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 14, 2011
Last Updated Date	July 25, 2012
Start Date ^ICMJE	February 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 14, 2011)	Recovery of GI Function [ Time Frame: up to 7 days of dosing or until hospital discharge ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01296620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 14, 2011)	Ancillary GI Functions [ Time Frame: up to 7 days of dosing or hospital discharge ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ulimorelin Study of Efficacy and Safety (ULISES 008)
Official Title ^ICMJE	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
Brief Summary	Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Gastrointestinal Dysmotility
Intervention ^ICMJE	Drug: Ulimorelin Intravenously (IV) 160 µg/kg daily (QD) Drug: Ulimorelin Invtravenously (IV) 480 µg/kg daily (QD) Drug: 5% dextrose in water Placebo
Study Arm (s)	Experimental: Experimental 1 Intervention: Drug: Ulimorelin Intravenously (IV) Experimental: Experimental 2 Intervention: Drug: Ulimorelin Invtravenously (IV) Placebo Comparator: Placebo Intervention: Drug: 5% dextrose in water
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	330
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men or women, 18 to 80 years of age, inclusive Scheduled to undergo open bowel resection with colonic anastomosis For women who can potentially become pregnant a pregnancy test at screening and admission must be negative Exclusion Criteria: Weight more than 200kg (441 pounds) Pregnant or breastfeeding Known history of drug or alcohol abuse within the previous year
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Bulgaria, Czech Republic, France, Lithuania, Romania

Administrative Information
NCT Number ^ICMJE	NCT01296620
Other Study ID Numbers ^ICMJE	TZP-101-CL-P008, 2010-023229-38
Has Data Monitoring Committee	Not Provided
Responsible Party	Tranzyme, Inc.
Study Sponsor ^ICMJE	Tranzyme, Inc.
Collaborators ^ICMJE	Norgine
Investigators ^ICMJE	Not Provided
Information Provided By	Tranzyme, Inc.
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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