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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tranzyme, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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