Clinical trial NCT01296620: Ulimorelin Study of Efficacy and Safety (ULISES 008)
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: 2011-02-15
Enrollment: 330
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: Glendale
country: United States
facility: Glendale Memorial Hospital
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Univ. of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto VA Health Care Ctr
state: California
city: Inverness
country: United States
facility: Citrus Memorial Hospital
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Powder Springs
country: United States
facility: ARS Clinical Trials
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: NOLA CVT Surgery
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Clackamas
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Monroeville
country: United States
facility: Forbes Regional Hospita
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
city: Nashville
country: United States
facility: Access Clinical Trials, Inc.
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Southwest Surgical Associates
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Research Institute
state: Washington
city: Sifua
country: Bulgaria
facility: UMHAT Emergency Medicine
city: Sofia
country: Bulgaria
facility: MHAT Tokuda Hospital Sofia
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMHAT Tzaritza Yoanna ISUL
city: Varna
country: Bulgaria
facility: UMHAT St. Marina
city: Brno
country: Czech Republic
facility: FN Brno
city: Brno
country: Czech Republic
facility: St. Anne's University Hospital
city: Jihlava
country: Czech Republic
facility: Hospital Jihlava
city: Liberec
country: Czech Republic
facility: Hospital Liberec
city: Olomouc
country: Czech Republic
facility: FN Olomouc
city: Prague
country: Czech Republic
facility: Fakutni Thomayerova nemocnica
city: Prague
country: Czech Republic
facility: University Hospital Bulovka
city: Bobigny
country: France
facility: CHU Avicenne
city: Clichy Paris
country: France
facility: Hopital Beaujon
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: CHU Rouen, Hopital Charles Nicolle
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital No. 2
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Clinics
city: Klaipeda
country: Lithuania
facility: Republican Klaipeda Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda Hospital
city: Vilnius
country: Lithuania
facility: Institute of Oncology at Vilnius University, Clinic of Surgery
city: Vilnius
country: Lithuania
facility: Vilnius City Univ. Hospital Clinic of Surgery
city: Cluj Napoca
country: Romania
facility: Institute regional de Gastroenterologie si Hepatologie
city: Oradea
country: Romania
facility: Spitalul Clinic Judetean de Urgenta
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.