Ulimorelin Study of Efficacy and Safety (ULISES 008)

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Gastrointestinal Dysmotility
Interventions
DRUG

Ulimorelin Intravenously (IV)

160 µg/kg daily (QD)

DRUG

Ulimorelin Invtravenously (IV)

480 µg/kg daily (QD)

DRUG

5% dextrose in water

Placebo

Trial Locations (50)

10021

Mount Sinai Hospital, New York

15146

Forbes Regional Hospita, Monroeville

15212

Allegheny General Hospital, Pittsburgh

15241

VA Pittsburgh Health Care System, Pittsburgh

23219

VCU Medical Center, Richmond

30127

ARS Clinical Trials, Powder Springs

32504

Pensacola Research Consultants, Pensacola

33606

Tampa General Hospital, Tampa

34452

Citrus Memorial Hospital, Inverness

Kaiser Permanente Northwest, Clackamas

37203

Access Clinical Trials, Inc., Nashville

39202

CRC of Jackson, Jackson

52242

University of Iowa Hospitals and Clinics, Iowa City

58122

Sanford Medical Center, Fargo

70115

NOLA CVT Surgery, New Orleans

77074

Southwest Surgical Associates, Houston

79905

Texas Tech University Health Sciences Center, El Paso

90033

Univ. of Southern California, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90806

Long Beach Memorial Medical Center, Long Beach

91204

Glendale Memorial Hospital, Glendale

94304

Palo Alto VA Health Care Ctr, Palo Alto

97239

Oregon Health and Science University, Portland

98405

MultiCare Research Institute, Tacoma

02111

Tufts Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Unknown

UMHAT Emergency Medicine, Sifua

MHAT Tokuda Hospital Sofia, Sofia

Military Medical Academy, Sofia

UMHAT Tzaritza Yoanna ISUL, Sofia

UMHAT St. Marina, Varna

FN Brno, Brno

St. Anne's University Hospital, Brno

Hospital Jihlava, Jihlava

Hospital Liberec, Liberec

FN Olomouc, Olomouc

Fakutni Thomayerova nemocnica, Prague

University Hospital Bulovka, Prague

CHU Avicenne, Bobigny

Hopital Beaujon, Clichy Paris

CHRU Lille, Lille

CHU Rouen, Hopital Charles Nicolle, Rouen

Institute regional de Gastroenterologie si Hepatologie, Cluj-Napoca

Spitalul Clinic Judetean de Urgenta, Oradea

LT-47144

Kaunas Clinical Hospital No. 2, Kaunas

LT50009

Kaunas Medical University Clinics, Kaunas

LT-92231

Republican Klaipeda Hospital, Klaipėda

LT-92288

Klaipeda Hospital, Klaipėda

LT-08660

Institute of Oncology at Vilnius University, Clinic of Surgery, Vilnius

LT-10207

Vilnius City Univ. Hospital Clinic of Surgery, Vilnius

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Norgine

INDUSTRY

lead

Tranzyme, Inc.

INDUSTRY