Back to resultsA Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
Primary Purpose
Ileus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MOA-728
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ileus focused on measuring POI, Hernia, Ventral Wall Hernia Repair, Post Operative Ileus
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).
Sites / Locations
- Kangnam-Gu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MOA-728 12 mg
MOA-728 24 mg
Placebo
Arm Description
Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Outcomes
Primary Outcome Measures
Time to First Bowel Movement
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
Secondary Outcome Measures
Time to Discharge Eligibility
Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.
Time to Discharge Order Written From the End of Surgery
The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.
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)
CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.
Full Information
NCT ID
NCT00528970
First Posted
September 11, 2007
Last Updated
August 12, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00528970
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2007 (Actual)
Primary Completion Date
February 5, 2008 (Actual)
Study Completion Date
February 5, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
POI, Hernia, Ventral Wall Hernia Repair, Post Operative Ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOA-728 12 mg
Arm Type
Experimental
Arm Description
Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Arm Title
MOA-728 24 mg
Arm Type
Experimental
Arm Description
Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Intervention Type
Drug
Intervention Name(s)
MOA-728
Other Intervention Name(s)
Methylnaltrexone
Intervention Description
MOA-728 will be administered per the dose and schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
Primary Outcome Measure Information:
Title
Time to First Bowel Movement
Description
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
Time Frame
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary Outcome Measure Information:
Title
Time to Discharge Eligibility
Description
Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.
Time Frame
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Title
Time to Discharge Order Written From the End of Surgery
Description
The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.
Time Frame
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Title
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)
Description
CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
City
Benton
State/Province
Arkansas
ZIP/Postal Code
72015
Country
United States
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
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
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5048
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8480
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
27599-7081
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
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
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
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5092
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
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
Bellevue
State/Province
Washington
ZIP/Postal Code
98005
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
City
Adelaide SA
ZIP/Postal Code
5006
Country
Australia
City
Elizabeth Vale SA
ZIP/Postal Code
5112
Country
Australia
City
Wilrijkstraat 10
State/Province
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
De Pintelaan 185
State/Province
Gent Belgium
ZIP/Postal Code
9000
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Augustenburger Platz 1
State/Province
Berlin
ZIP/Postal Code
13353 DEU
Country
Germany
City
Nussbaumstrasse 20
State/Province
Muenchen
ZIP/Postal Code
80336 DEU
Country
Germany
City
Heidelberg
ZIP/Postal Code
110 69120
Country
Germany
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Corso Giovecca 203
State/Province
Ferrara
ZIP/Postal Code
44100
Country
Italy
City
Gemelli
State/Province
Rome
ZIP/Postal Code
00168
Country
Italy
City
Padova
State/Province
Via Giustiniani 2
ZIP/Postal Code
35100
Country
Italy
City
Bergamo
ZIP/Postal Code
24040
Country
Italy
Facility Name
Kangnam-Gu
City
Seoul
ZIP/Postal Code
135 710
Country
Korea, Republic of
City
Jan Toorpstraat 164
State/Province
Amsterdam
ZIP/Postal Code
1061
Country
Netherlands
City
Roosendaal
ZIP/Postal Code
4708
Country
Netherlands
City
Polnocna 42
State/Province
Lodz
ZIP/Postal Code
91 425
Country
Poland
City
Powstancow Wielkopolskich 72
State/Province
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Durban Kwa-Zulu
State/Province
Natal
ZIP/Postal Code
3201
Country
South Africa
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Moreletapark Pretoria
ZIP/Postal Code
0044
Country
South Africa
City
Pretoria Gauteng
ZIP/Postal Code
0084
Country
South Africa
City
Pretoria Gauteng
ZIP/Postal Code
0181
Country
South Africa
City
Pretoria
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
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