- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00401375
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
August 12, 2019 updated by: Bausch Health Americas, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
524
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Tarrytown, New York, United States, 10591
- Progenics Pharmaceuticals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MNTX 12 mg
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).
|
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Other Names:
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Experimental: MNTX 24 mg
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).
|
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Other Names:
|
Placebo Comparator: Placebo
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).
|
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First Bowel Movement
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
|
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.
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Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Discharge Eligibility
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
|
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.
|
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
|
Time to Discharge Order Written From the End of Surgery
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
|
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.
|
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
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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)
Time Frame: 0 and 24 hours
|
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.
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0 and 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2006
Primary Completion (Actual)
February 29, 2008
Study Completion (Actual)
February 29, 2008
Study Registration Dates
First Submitted
November 16, 2006
First Submitted That Met QC Criteria
November 17, 2006
First Posted (Estimate)
November 20, 2006
Study Record Updates
Last Update Posted (Actual)
September 4, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNTX 3301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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