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Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00401375
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Post-Operative Ileus (POI) Drug: Methylnaltrexone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 31, 2006
Actual Primary Completion Date : February 29, 2008
Actual Study Completion Date : February 29, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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).
Drug: Methylnaltrexone
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Other Name: MNTX

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).
Drug: Methylnaltrexone
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Other Name: MNTX

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).
Drug: Placebo
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401375


Locations
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United States, New York
Progenics Pharmaceuticals
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Bausch Health Americas, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Lindsey Mathew Bausch Health Americas, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00401375    
Other Study ID Numbers: MNTX 3301
First Posted: November 20, 2006    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylnaltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents