Back to resultsStudy of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Primary Purpose
Post-Operative Ileus (POI)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylnaltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Ileus (POI)
Eligibility Criteria
Inclusion Criteria:
- Male and female participants at least 18 years of age.
- All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Participants must sign an informed consent form (ICF).
- Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
- Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
- Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
Exclusion Criteria:
- Participants who received any investigational new drug in the 30 days prior to screening visit.
- Females who are pregnant or lactating.
Sites / Locations
- Progenics Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MNTX 12 mg
MNTX 24 mg
Placebo
Arm Description
Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
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 both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were considered treatment failures. 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 were considered treatment failures. Analysis was performed by Kaplan-Meier estimate.
Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 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
NCT00401375
First Posted
November 16, 2006
Last Updated
August 12, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00401375
Brief Title
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Official Title
A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2006 (Actual)
Primary Completion Date
February 29, 2008 (Actual)
Study Completion Date
February 29, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Ileus (POI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
524 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MNTX 12 mg
Arm Type
Experimental
Arm Description
Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Arm Title
MNTX 24 mg
Arm Type
Experimental
Arm Description
Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone
Other Intervention Name(s)
MNTX
Intervention Description
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective 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 both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were 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
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 were 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 0 or 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
0 and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female participants at least 18 years of age.
All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
Participants must sign an informed consent form (ICF).
Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
Exclusion Criteria:
Participants who received any investigational new drug in the 30 days prior to screening visit.
Females who are pregnant or lactating.
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:
Facility Name
Progenics Pharmaceuticals
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States
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
Links:
URL
http://www.progenics.com
Description
Related Info
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Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
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