Ulimorelin Study of Efficacy and Safety (ULISES 008)

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)

330

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

  • Bulgaria
      • Sifua, Bulgaria
        • UMHAT Emergency Medicine
      • Sofia, Bulgaria
        • MHAT Tokuda Hospital Sofia
      • Sofia, Bulgaria
        • Military Medical Academy
      • Sofia, Bulgaria
        • UMHAT Tzaritza Yoanna ISUL
      • Varna, Bulgaria
        • UMHAT St. Marina
  • Czech Republic
      • Brno, Czech Republic
        • FN Brno
      • Brno, Czech Republic
        • St. Anne's University Hospital
      • Jihlava, Czech Republic
        • Hospital Jihlava
      • Liberec, Czech Republic
        • Hospital Liberec
      • Olomouc, Czech Republic
        • FN Olomouc
      • Prague, Czech Republic
        • Fakutni Thomayerova nemocnica
      • Prague, Czech Republic
        • University Hospital Bulovka
  • France
      • Bobigny, France
        • CHU Avicenne
      • Clichy Paris, France
        • Hopital Beaujon
      • Lille, France
        • CHRU Lille
      • Rouen, France
        • CHU Rouen, Hôpital Charles Nicolle
  • Lithuania
      • Kaunas, Lithuania, LT-47144
        • Kaunas Clinical Hospital No. 2
      • Kaunas, Lithuania, LT50009
        • Kaunas Medical University Clinics
      • Klaipeda, Lithuania, LT-92231
        • Republican Klaipeda Hospital
      • Klaipeda, Lithuania, LT-92288
        • Klaipeda Hospital
      • Vilnius, Lithuania, LT-08660
        • Institute of Oncology at Vilnius University, Clinic of Surgery
      • Vilnius, Lithuania, LT-10207
        • Vilnius City Univ. Hospital Clinic of Surgery
  • Romania
      • Cluj Napoca, Romania
        • Institute regional de Gastroenterologie si Hepatologie
      • Oradea, Romania
        • Spitalul Clinic Județean de Urgență
  • United States
    • California
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Univ. of Southern California
      • Palo Alto, California, United States, 94304
        • Palo Alto VA Health Care Ctr
    • Florida
      • Inverness, Florida, United States, 34452
        • Citrus Memorial Hospital
      • Pensacola, Florida, United States, 32504
        • Pensacola Research Consultants
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Powder Springs, Georgia, United States, 30127
        • ARS Clinical Trials
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • NOLA CVT Surgery
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CRC of Jackson
    • New York
      • New York, New York, United States, 10021
        • Mount Sinai Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center
    • Oregon
      • Clackamas, Oregon, United States, 34452
        • Kaiser Permanente Northwest
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Regional Hospita
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15241
        • VA Pittsburgh Health Care System
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials, Inc.
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
      • Houston, Texas, United States, 77074
        • Southwest Surgical Associates
    • Virginia
      • Richmond, Virginia, United States, 23219
        • VCU Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Research Institute

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
Placebo Comparator: Placebo
Drug: 5% dextrose in water
Placebo
Experimental: Experimental 1
Drug: Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
Experimental: Experimental 2
Drug: Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)

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

February 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 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-P008
  • 2010-023229-38 (EudraCT Number)

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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