Ulimorelin Study of Efficacy and Safety (ULISES 007)

PHASE3CompletedINTERVENTIONAL
Enrollment

332

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Gastrointestinal Dysmotility
Interventions
DRUG

Ulimorelin Intravenously (IV)

480 microg/kg daily (QD)

DRUG

Ulimorelin Intravenously (IV)

160 microg/kg daily (QD)

DRUG

5% dextrose in water

Placebo

Trial Locations (45)

10021

Mt. Sinai Hospital, New York

27710

Duke University Medical Center, Durham

30127

ARS Clinical Trials, Powder Springs

32216

Jacksonville Center for Clinical Research, Jacksonville

32504

Pensacola Research Consultants, Pensacola

33323

Sunrise Clinical Research, Inc., Sunrise

34452

Nature Coast Clinical Research, Inverness

39202

CRC of Jackson, Jackson

40202

Univ. of Louisville, Dept. of Surgery, Louisville

44106

University Hospitals Case Medical Ctr., Cleveland

62702

So. Illinois Univ. School of Medicine, Springfield

68121

Creighton Univ. Medical Ctr., Omaha

76104

JPS Health Network, Dept. of Surgery, Fort Worth

77074

Southwest Surgical Associates, Houston

80220

Denver VA Medical Center, Denver

90033

USC, Colorectal Surgery Division, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

92708

Fountain Valley Regional Hospital, Fountain Valley

Orange Coast Memorial Med. Ctr., Fountain Valley

97015

Mt. Talbert Medical Offices, Clackamas

97701

Bend Memorial Clinic, Bend

01655

UMass Memorial Medical Center, Worcester

17033-0850

Penn State Milton S. Hershey Medical Center, Hershey

Unknown

JohnFerenc Del-pesti Hospital, Budapest

Petz Aladar County Education Hospital, Győr

County Hospital of Kecskemet, Kecskemét

St. Gyorgy Hospital of Fejer County, Székesfehérvár

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia

Policlinico Universitario Agostino Gemelli -Univ, Rome

IRCCS Policlinico San Donato, San Donato

Plac Hallera, Genl Surgery, Lodz

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

Hospital Wolski, Warsaw

"Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor", Cluj-Napoca

Spitalul Clinic Judetean de Urgente, Iași

Spitalul Clinic Judetean de Urgenta Oradea, Oradea

Spitalul Clinic Judetean Mures, Târgu Mureş

Spitalul Clinic Judetean de Urgenta Timisoara, Timișoara

Clinical Center of Serbia, Belgrade

Clinical Hospital Bezanijska Kosa, Belgrade

Clinical Hospital Center Zvezdara, Belgrade

Clinical Center Nis, Niš

Nottingham University Hospital, Nottingham

Scarborough Hospital, Scarborough

Northern General Hospital, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Norgine

INDUSTRY

lead

Tranzyme, Inc.

INDUSTRY