Clinical trial NCT00387309: Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Bowel Dysfunction
Keywords: Bowel
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.


Eligibility criteria: Inclusion:

* Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
* Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
* Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

* Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
* Subjects with a recent history (\<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
* Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)

Primary outcomes:
measure: Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Fort Smith
country: United States
state: Arkansas
city: Chula Vista
country: United States
state: California
city: Colton
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Jose
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Bay Minette
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Saint Paul
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Albany
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Danville
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Camperdown
country: Australia
state: New South Wales
city: Elizabeth Vale
country: Australia
state: South Australia
city: Woodville South
country: Australia
state: South Australia
city: Beograd
country: Former Serbia and Montenegro
city: Berlin
country: Germany
city: Halle
country: Germany
city: Heidelberg
country: Germany
city: Munchen
country: Germany
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Pecs
country: Hungary
city: Szekesfehervar
country: Hungary
city: Osio Sotto
country: Italy
state: Zingonia
city: Bologna
country: Italy
city: Ferrara
country: Italy
city: Genova
country: Italy
city: Monza
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pietermaritzburg
country: South Africa
state: Kwa-Zulu Natal
city: Cape Town
country: South Africa
state: Western Cape
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
citation: Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8. doi: 10.1007/DCR.0b013e3182092bde.