Ulimorelin Study of Efficacy and Safety (ULISES 008)

Gastrointestinal Dysmotility Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296620
• Other study ID #: TZP-101-CL-P008
• Secondary ID: 2010-023229-38
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2011
• Last updated: July 25, 2012
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Tranzyme, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationLithuania: State Medicines Control Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Dysmotility

Intervention

Drug:
• Ulimorelin Intravenously (IV)
160 µg/kg daily (QD)
• Ulimorelin Invtravenously (IV)
480 µg/kg daily (QD)
• 5% dextrose in water
Placebo

Locations

Country	Name	City	State
Bulgaria	UMHAT Emergency Medicine	Sifua
Bulgaria	MHAT Tokuda Hospital Sofia	Sofia
Bulgaria	Military Medical Academy	Sofia
Bulgaria	UMHAT Tzaritza Yoanna ISUL	Sofia
Bulgaria	UMHAT St. Marina	Varna
Czech Republic	FN Brno	Brno
Czech Republic	St. Anne's University Hospital	Brno
Czech Republic	Hospital Jihlava	Jihlava
Czech Republic	Hospital Liberec	Liberec
Czech Republic	FN Olomouc	Olomouc
Czech Republic	Fakutni Thomayerova nemocnica	Prague
Czech Republic	University Hospital Bulovka	Prague
France	CHU Avicenne	Bobigny
France	Hopital Beaujon	Clichy Paris
France	CHRU Lille	Lille
France	CHU Rouen, Hopital Charles Nicolle	Rouen
Lithuania	Kaunas Clinical Hospital No. 2	Kaunas
Lithuania	Kaunas Medical University Clinics	Kaunas
Lithuania	Klaipeda Hospital	Klaipeda
Lithuania	Republican Klaipeda Hospital	Klaipeda
Lithuania	Institute of Oncology at Vilnius University, Clinic of Surgery	Vilnius
Lithuania	Vilnius City Univ. Hospital Clinic of Surgery	Vilnius
Romania	Institute regional de Gastroenterologie si Hepatologie	Cluj Napoca
Romania	Spitalul Clinic Judetean de Urgenta	Oradea
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Kaiser Permanente Northwest	Clackamas	Oregon
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Sanford Medical Center	Fargo	North Dakota
United States	Glendale Memorial Hospital	Glendale	California
United States	Southwest Surgical Associates	Houston	Texas
United States	Citrus Memorial Hospital	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	CRC of Jackson	Jackson	Mississippi
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Univ. of Southern California	Los Angeles	California
United States	Forbes Regional Hospita	Monroeville	Pennsylvania
United States	Access Clinical Trials, Inc.	Nashville	Tennessee
United States	NOLA CVT Surgery	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	Palo Alto VA Health Care Ctr	Palo Alto	California
United States	Pensacola Research Consultants	Pensacola	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	ARS Clinical Trials	Powder Springs	Georgia
United States	VCU Medical Center	Richmond	Virginia
United States	MultiCare Research Institute	Tacoma	Washington
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Tranzyme, Inc.	Norgine

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  France,  Lithuania,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of GI Function		up to 7 days of dosing or until hospital discharge	No
Secondary	Ancillary GI Functions		up to 7 days of dosing or hospital discharge	No