Clinical trial NCT01285570: Ulimorelin Study of Efficacy and Safety (ULISES 007)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Dysmotility
Lead sponsor: Tranzyme, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Norgine
First posted: 2011-01-28
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recovery of GI Function
timeFrame: up to 7 days of dosing or until hospital discharge
Secondary outcomes:
measure: Ancillary GI Functions
timeFrame: up to 7 days of dosing or hospital discharge
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Fountain Valley Regional Hospital
state: California
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Med. Ctr.
state: California
city: Los Angeles
country: United States
facility: USC, Colorectal Surgery Division
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Sunrise
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Powder Springs
country: United States
facility: ARS Clinical Trials
state: Georgia
city: Springfield
country: United States
facility: So. Illinois Univ. School of Medicine
state: Illinois
city: Louisville
country: United States
facility: Univ. of Louisville, Dept. of Surgery
state: Kentucky
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Omaha
country: United States
facility: Creighton Univ. Medical Ctr.
state: Nebraska
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Ctr.
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Clackamas
country: United States
facility: Mt. Talbert Medical Offices
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Fort Worth
country: United States
facility: JPS Health Network, Dept. of Surgery
state: Texas
city: Houston
country: United States
facility: Southwest Surgical Associates
state: Texas
city: Budapest
country: Hungary
facility: JohnFerenc Del-pesti Hospital
city: Gyor
country: Hungary
facility: Petz Aladar County Education Hospital
city: Kecskemet
country: Hungary
facility: County Hospital of Kecskemet
city: Szekesfehervar
country: Hungary
facility: St. Gyorgy Hospital of Fejer County
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli -Univ
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
city: Lodz
country: Poland
facility: Plac Hallera, Genl Surgery
city: Lodz
country: Poland
facility: Univ. Hospital #1, N. Barlicki Med. Univ.
city: Warsaw
country: Poland
facility: Hospital Wolski
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic de Urgenta "Prof. Dr. Octavian Fodor"
city: Iasi
country: Romania
facility: Spitalul Clinic Judetean de Urgente
city: Oradea
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Oradea
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Scarborough
country: United Kingdom
facility: Scarborough Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
References:
citation: Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.