Ulimorelin Study of Efficacy and Safety (ULISES 007)

Last updated: July 25, 2012
Sponsor: Tranzyme, Inc.
Overall Status: Completed

Phase

3

Condition

Irritable Bowel Syndrome (Ibs)

Gastroparesis

Ileus

Treatment

N/A

Clinical Study ID

NCT01285570
TZP-101-CL-P007
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andadmission must be negative.

Exclusion

Exclusion Criteria:

  • Weight more than 200kg (441 pounds)

  • Pregnant or breastfeeding

  • Known history of drug or alcohol abuse within the previous year.

Study Design

Total Participants: 332
Study Start date:
January 01, 2011
Estimated Completion Date:
January 31, 2012

Connect with a study center

  • JohnFerenc Del-pesti Hospital

    Budapest,
    Hungary

    Site Not Available

  • Petz Aladar County Education Hospital

    Gyor,
    Hungary

    Site Not Available

  • County Hospital of Kecskemet

    Kecskemet,
    Hungary

    Site Not Available

  • St. Gyorgy Hospital of Fejer County

    Szekesfehervar,
    Hungary

    Site Not Available

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli -Univ

    Rome,
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    San Donato,
    Italy

    Site Not Available

  • Plac Hallera, Genl Surgery

    Lodz,
    Poland

    Site Not Available

  • Univ. Hospital #1, N. Barlicki Med. Univ.

    Lodz,
    Poland

    Site Not Available

  • Hospital Wolski

    Warsaw,
    Poland

    Site Not Available

  • Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"

    Cluj Napoca,
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgente

    Iasi,
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Oradea

    Oradea,
    Romania

    Site Not Available

  • Spitalul Clinic Judetean Mures

    Targu Mures,
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Timisoara

    Timisoara,
    Romania

    Site Not Available

  • Clinical Center of Serbia

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Hospital Bezanijska Kosa

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Center Nis

    Nis,
    Serbia

    Site Not Available

  • Nottingham University Hospital

    Nottingham,
    United Kingdom

    Site Not Available

  • Scarborough Hospital

    Scarborough,
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield,
    United Kingdom

    Site Not Available

  • Fountain Valley Regional Hospital

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Orange Coast Memorial Med. Ctr.

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • USC, Colorectal Surgery Division

    Los Angeles, California 90033
    United States

    Site Not Available

  • Denver VA Medical Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Pensacola Research Consultants

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Sunrise Clinical Research, Inc.

    Sunrise, Florida 33323
    United States

    Site Not Available

  • ARS Clinical Trials

    Powder Springs, Georgia 30127
    United States

    Site Not Available

  • So. Illinois Univ. School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Univ. of Louisville, Dept. of Surgery

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • CRC of Jackson

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Creighton Univ. Medical Ctr.

    Omaha, Nebraska 68121
    United States

    Site Not Available

  • Mt. Sinai Hospital

    New York, New York 10021
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University Hospitals Case Medical Ctr.

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Bend Memorial Clinic

    Bend, Oregon 97701
    United States

    Site Not Available

  • Mt. Talbert Medical Offices

    Clackamas, Oregon 97015
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • JPS Health Network, Dept. of Surgery

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Southwest Surgical Associates

    Houston, Texas 77074
    United States

    Site Not Available

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