Ulimorelin Study of Efficacy and Safety (ULISES 007)

Phase 3

Completed

• Conditions: Gastrointestinal Dysmotility
• Interventions: Drug: Ulimorelin Intravenously (IV); Drug: 5% dextrose in water

• Registration Number: NCT01285570
• Lead Sponsor: Tranzyme, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 2	Ulimorelin Intravenously (IV)	-
experimental 1	Ulimorelin Intravenously (IV)	-
Placebo	5% dextrose in water	Placebo comparator daily (QD)

Primary Outcome Measures

Name	Time	Method
Recovery of GI Function	up to 7 days of dosing or until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Ancillary GI Functions	up to 7 days of dosing or hospital discharge

Trial Locations

Locations (45)

Univ. Hospital #1, N. Barlicki Med. Univ.; 🇵🇱 Lodz, Poland

Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"; 🇷🇴 Cluj Napoca, Romania

Spitalul Clinic Judetean de Urgenta Timisoara; 🇷🇴 Timisoara, Romania

Spitalul Clinic Judetean de Urgente; 🇷🇴 Iasi, Romania

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Clinical Hospital Bezanijska Kosa; 🇷🇸 Belgrade, Serbia

Clinical Hospital Center Zvezdara; 🇷🇸 Belgrade, Serbia

Fountain Valley Regional Hospital; 🇺🇸 Fountain Valley, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Orange Coast Memorial Med. Ctr.; 🇺🇸 Fountain Valley, California, United States

USC, Colorectal Surgery Division; 🇺🇸 Los Angeles, California, United States

Sunrise Clinical Research, Inc.; 🇺🇸 Sunrise, Florida, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Nature Coast Clinical Research; 🇺🇸 Inverness, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

So. Illinois Univ. School of Medicine; 🇺🇸 Springfield, Illinois, United States

St. Gyorgy Hospital of Fejer County; 🇭🇺 Szekesfehervar, Hungary

CRC of Jackson; 🇺🇸 Jackson, Mississippi, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

University Hospitals Case Medical Ctr.; 🇺🇸 Cleveland, Ohio, United States

Petz Aladar County Education Hospital; 🇭🇺 Gyor, Hungary

Mt. Talbert Medical Offices; 🇺🇸 Clackamas, Oregon, United States

Bend Memorial Clinic; 🇺🇸 Bend, Oregon, United States

County Hospital of Kecskemet; 🇭🇺 Kecskemet, Hungary

Policlinico Universitario Agostino Gemelli -Univ; 🇮🇹 Rome, Italy

Spitalul Clinic Judetean de Urgenta Oradea; 🇷🇴 Oradea, Romania

Hospital Wolski; 🇵🇱 Warsaw, Poland

Spitalul Clinic Judetean Mures; 🇷🇴 Targu Mures, Romania

Scarborough Hospital; 🇬🇧 Scarborough, United Kingdom

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

Fondazione I.R.C.C.S. Policlinico San Matteo; 🇮🇹 Pavia, Italy

IRCCS Policlinico San Donato; 🇮🇹 San Donato, Italy

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Pensacola Research Consultants; 🇺🇸 Pensacola, Florida, United States

ARS Clinical Trials; 🇺🇸 Powder Springs, Georgia, United States

JPS Health Network, Dept. of Surgery; 🇺🇸 Fort Worth, Texas, United States

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Denver VA Medical Center; 🇺🇸 Denver, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Univ. of Louisville, Dept. of Surgery; 🇺🇸 Louisville, Kentucky, United States

Southwest Surgical Associates; 🇺🇸 Houston, Texas, United States

Plac Hallera, Genl Surgery; 🇵🇱 Lodz, Poland

Clinical Center Nis; 🇷🇸 Nis, Serbia

Creighton Univ. Medical Ctr.; 🇺🇸 Omaha, Nebraska, United States

JohnFerenc Del-pesti Hospital; 🇭🇺 Budapest, Hungary