Back to resultsStudy Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Primary Purpose
Post Operative Bowel Dysfunction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Methylnaltrexone (MOA-728)
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Bowel Dysfunction focused on measuring Bowel
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)
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
Full Information
NCT ID
NCT00387309
First Posted
October 11, 2006
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00387309
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Bowel Dysfunction
Keywords
Bowel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
495 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone (MOA-728)
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Cohn
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
92114
Country
United States
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Bay Minette
State/Province
Florida
ZIP/Postal Code
36507
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
322224
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55104
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Beograd
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Halle
ZIP/Postal Code
06097
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Munchen
ZIP/Postal Code
80336
Country
Germany
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Osio Sotto
State/Province
Zingonia
ZIP/Postal Code
24040
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Monza
ZIP/Postal Code
20052
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
City
Pietermaritzburg
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
3201
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
21471758
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.
Results Reference
derived
Learn more about this trial
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
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