Ulimorelin Study of Efficacy and Safety (ULISES 007) (ULISES)

July 25, 2012 updated by: Tranzyme, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • JohnFerenc Del-pesti Hospital
      • Gyor, Hungary
        • Petz Aladar County Education Hospital
      • Kecskemet, Hungary
        • County Hospital of Kecskemet
      • Szekesfehervar, Hungary
        • St. Gyorgy Hospital of Fejer County
  • Italy
      • Pavia, Italy
        • Fondazione I.R.C.C.S. Policlinico San Matteo
      • Rome, Italy
        • Policlinico Universitario Agostino Gemelli -Univ
      • San Donato, Italy
        • IRCCS Policlinico San Donato
  • Poland
      • Lodz, Poland
        • Plac Hallera, Genl Surgery
      • Lodz, Poland
        • Univ. Hospital #1, N. Barlicki Med. Univ.
      • Warsaw, Poland
        • Hospital Wolski
  • Romania
      • Cluj Napoca, Romania
        • Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"
      • Iasi, Romania
        • Spitalul Clinic Judetean de Urgente
      • Oradea, Romania
        • Spitalul Clinic Judetean de Urgenta Oradea
      • Targu Mures, Romania
        • Spitalul Clinic Judetean Mures
      • Timisoara, Romania
        • Spitalul Clinic Judetean de Urgenta Timisoara
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Clinical Hospital Bezanijska Kosa
      • Belgrade, Serbia
        • Clinical Hospital Center Zvezdara
      • Nis, Serbia
        • Clinical Center Nis
  • United Kingdom
      • Nottingham, United Kingdom
        • Nottingham University Hospital
      • Scarborough, United Kingdom
        • Scarborough Hospital
      • Sheffield, United Kingdom
        • Northern General Hospital
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Fountain Valley Regional Hospital
      • Fountain Valley, California, United States, 92708
        • Orange Coast Memorial Med. Ctr.
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC, Colorectal Surgery Division
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VA Medical Center
    • Florida
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Pensacola, Florida, United States, 32504
        • Pensacola Research Consultants
      • Sunrise, Florida, United States, 33323
        • Sunrise Clinical Research, Inc.
    • Georgia
      • Powder Springs, Georgia, United States, 30127
        • ARS Clinical Trials
    • Illinois
      • Springfield, Illinois, United States, 62702
        • So. Illinois Univ. School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Univ. of Louisville, Dept. of Surgery
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Umass Memorial Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CRC of Jackson
    • Nebraska
      • Omaha, Nebraska, United States, 68121
        • Creighton Univ. Medical Ctr.
    • New York
      • New York, New York, United States, 10021
        • Mt. Sinai Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Ctr.
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Clackamas, Oregon, United States, 97015
        • Mt. Talbert Medical Offices
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S. Hershey Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • JPS Health Network, Dept. of Surgery
      • Houston, Texas, United States, 77074
        • Southwest Surgical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 2
Drug: Ulimorelin Intravenously (IV)
480 microg/kg daily (QD)
Drug: Ulimorelin Intravenously (IV)
160 microg/kg daily (QD)
Experimental: experimental 1
Drug: Ulimorelin Intravenously (IV)
480 microg/kg daily (QD)
Drug: Ulimorelin Intravenously (IV)
160 microg/kg daily (QD)
Placebo Comparator: Placebo
Placebo comparator daily (QD)
Drug: 5% dextrose in water
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery of GI Function
Time Frame: up to 7 days of dosing or until hospital discharge
up to 7 days of dosing or until hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Ancillary GI Functions
Time Frame: up to 7 days of dosing or hospital discharge
up to 7 days of dosing or hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tranzyme, Inc.

Collaborators

Norgine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 28, 2011

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • TZP-101-CL-P007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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