Ulimorelin Study of Efficacy and Safety (ULISES 007)

Gastrointestinal Dysmotility Clinical Trial

— ULISES  

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: NCT01285570
• Other study ID #: TZP-101-CL-P007
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2011
• Last updated: July 25, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Tranzyme, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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: 332
• Est. completion date: January 2012
• Est. primary completion date: January 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)
480 microg/kg daily (QD)
• Ulimorelin Intravenously (IV)
160 microg/kg daily (QD)
• 5% dextrose in water
Placebo

Locations

Country	Name	City	State
Hungary	JohnFerenc Del-pesti Hospital	Budapest
Hungary	Petz Aladar County Education Hospital	Gyor
Hungary	County Hospital of Kecskemet	Kecskemet
Hungary	St. Gyorgy Hospital of Fejer County	Szekesfehervar
Italy	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia
Italy	Policlinico Universitario Agostino Gemelli -Univ	Rome
Italy	IRCCS Policlinico San Donato	San Donato
Poland	Plac Hallera, Genl Surgery	Lodz
Poland	Univ. Hospital #1, N. Barlicki Med. Univ.	Lodz
Poland	Hospital Wolski	Warsaw
Romania	Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"	Cluj Napoca
Romania	Spitalul Clinic Judetean de Urgente	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Oradea	Oradea
Romania	Spitalul Clinic Judetean Mures	Targu Mures
Romania	Spitalul Clinic Judetean de Urgenta Timisoara	Timisoara
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Hospital Bezanijska Kosa	Belgrade
Serbia	Clinical Hospital Center Zvezdara	Belgrade
Serbia	Clinical Center Nis	Nis
United Kingdom	Nottingham University Hospital	Nottingham
United Kingdom	Scarborough Hospital	Scarborough
United Kingdom	Northern General Hospital	Sheffield
United States	Bend Memorial Clinic	Bend	Oregon
United States	Mt. Talbert Medical Offices	Clackamas	Oregon
United States	University Hospitals Case Medical Ctr.	Cleveland	Ohio
United States	Denver VA Medical Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	JPS Health Network, Dept. of Surgery	Fort Worth	Texas
United States	Fountain Valley Regional Hospital	Fountain Valley	California
United States	Orange Coast Memorial Med. Ctr.	Fountain Valley	California
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Southwest Surgical Associates	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	CRC of Jackson	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC, Colorectal Surgery Division	Los Angeles	California
United States	Univ. of Louisville, Dept. of Surgery	Louisville	Kentucky
United States	Mt. Sinai Hospital	New York	New York
United States	Creighton Univ. Medical Ctr.	Omaha	Nebraska
United States	Pensacola Research Consultants	Pensacola	Florida
United States	ARS Clinical Trials	Powder Springs	Georgia
United States	So. Illinois Univ. School of Medicine	Springfield	Illinois
United States	Sunrise Clinical Research, Inc.	Sunrise	Florida
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tranzyme, Inc.	Norgine

Countries where clinical trial is conducted

United States,  Hungary,  Italy,  Poland,  Romania,  Serbia,  United Kingdom, 

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