Clinical trial NCT00528970: A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus After Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ileus
Keywords: POI
Hernia
Ventral Wall Hernia Repair
Post Operative Ileus
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2007-09-14
Enrollment: 374
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: This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to \[≥\]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.


Eligibility criteria: Inclusion Criteria:

* Males and females, ages 18 and older.
* Scheduled for ventral wall hernia repair with general anesthesia.
* Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

* Received investigational drug or procedure within 30 days of randomization.
* Women who are pregnant or lactating.
* Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate \[GFR\] formula) less than or equal to (\</=) 50 milliliters/minute (mL/min).

Primary outcomes:
measure: Time to First Bowel Movement
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary outcomes:
measure: Time to Discharge Eligibility
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
measure: Time to Discharge Order Written From the End of Surgery
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
measure: Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at Day 2 (24 Hours) as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)
timeFrame: Day 2
Other outcomes:
Locations:
city: Benton
country: United States
state: Arkansas
city: Colton
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Jose
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Inverness
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Peoria
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: New Brunswick
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
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: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Sioux Falls
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide SA
country: Australia
city: Elizabeth Vale SA
country: Australia
city: Wilrijkstraat 10
country: Belgium
state: Edegem
city: De Pintelaan 185
country: Belgium
state: Gent Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Augustenburger Platz 1
country: Germany
state: Berlin
city: Nussbaumstrasse 20
country: Germany
state: Muenchen
city: Heidelberg
country: Germany
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szekesfehervar
country: Hungary
city: Veszprem
country: Hungary
city: Corso Giovecca 203
country: Italy
state: Ferrara
city: Gemelli
country: Italy
state: Rome
city: Padova
country: Italy
state: Via Giustiniani 2
city: Bergamo
country: Italy
city: Seoul
country: Korea, Republic of
facility: Kangnam-Gu
city: Jan Toorpstraat 164
country: Netherlands
state: Amsterdam
city: Roosendaal
country: Netherlands
city: Polnocna 42
country: Poland
state: Lodz
city: Powstancow Wielkopolskich 72
country: Poland
state: Szczecin
city: Bydgoszcz
country: Poland
city: Durban Kwa-Zulu
country: South Africa
state: Natal
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Moreletapark Pretoria
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Pretoria
country: South Africa
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: