Ulimorelin Study of Efficacy and Safety (ULISES 008)

Phase 3

Completed

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

• Registration Number: NCT01296620
• 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: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 1	Ulimorelin Intravenously (IV)	-
Experimental 2	Ulimorelin Invtravenously (IV)	-
Placebo	5% dextrose in water	-

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 (50)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

MHAT Tokuda Hospital Sofia; 🇧🇬 Sofia, Bulgaria

UMHAT Emergency Medicine; 🇧🇬 Sifua, Bulgaria

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

UMHAT Tzaritza Yoanna ISUL; 🇧🇬 Sofia, Bulgaria

University Hospital Bulovka; 🇨🇿 Prague, Czech Republic

Klaipeda Hospital; 🇱🇹 Klaipeda, Lithuania

Hospital Jihlava; 🇨🇿 Jihlava, Czech Republic

Hospital Liberec; 🇨🇿 Liberec, Czech Republic

Kaunas Clinical Hospital No. 2; 🇱🇹 Kaunas, Lithuania

Kaunas Medical University Clinics; 🇱🇹 Kaunas, Lithuania

Republican Klaipeda Hospital; 🇱🇹 Klaipeda, Lithuania

CHU Rouen, Hopital Charles Nicolle; 🇫🇷 Rouen, France

Citrus Memorial Hospital; 🇺🇸 Inverness, Florida, United States

Univ. of Southern California; 🇺🇸 Los Angeles, California, United States

CHU Avicenne; 🇫🇷 Bobigny, France

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

FN Olomouc; 🇨🇿 Olomouc, Czech Republic

Vilnius City Univ. Hospital Clinic of Surgery; 🇱🇹 Vilnius, Lithuania

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

Kaiser Permanente Northwest; 🇺🇸 Clackamas, Oregon, United States

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

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

Hopital Beaujon; 🇫🇷 Clichy Paris, France

CHRU Lille; 🇫🇷 Lille, France

MultiCare Research Institute; 🇺🇸 Tacoma, Washington, United States

FN Brno; 🇨🇿 Brno, Czech Republic

St. Anne's University Hospital; 🇨🇿 Brno, Czech Republic

Fakutni Thomayerova nemocnica; 🇨🇿 Prague, Czech Republic

UMHAT St. Marina; 🇧🇬 Varna, Bulgaria

Institute of Oncology at Vilnius University, Clinic of Surgery; 🇱🇹 Vilnius, Lithuania

Spitalul Clinic Judetean de Urgenta; 🇷🇴 Oradea, Romania

Sanford Medical Center; 🇺🇸 Fargo, North Dakota, United States

Glendale Memorial Hospital; 🇺🇸 Glendale, California, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

NOLA CVT Surgery; 🇺🇸 New Orleans, Louisiana, United States

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

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Palo Alto VA Health Care Ctr; 🇺🇸 Palo Alto, California, United States

Texas Tech University Health Sciences Center; 🇺🇸 El Paso, Texas, United States

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

VA Pittsburgh Health Care System; 🇺🇸 Pittsburgh, Pennsylvania, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Forbes Regional Hospita; 🇺🇸 Monroeville, Pennsylvania, United States

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

Access Clinical Trials, Inc.; 🇺🇸 Nashville, Tennessee, United States

VCU Medical Center; 🇺🇸 Richmond, Virginia, United States

Institute regional de Gastroenterologie si Hepatologie; 🇷🇴 Cluj Napoca, Romania