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

NCT00401375 | Completed Phase 3 Results

• 1 other identifier: MNTX 3301
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Ileus (POI)

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Secondary Outcomes (3)

• Time to Discharge Eligibility

  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

  Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

• 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)

  0 and 24 hours

Study Arms (3)

MNTX 12 mg

EXPERIMENTAL

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

MNTX 24 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Methylnaltrexone DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

Also known as: MNTX

MNTX 12 mg; MNTX 24 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who received any investigational new drug in the 30 days prior to screening visit.
• Females who are pregnant or lactating.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Location

Related Publications (1)

• 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.

  PMID: 21471758 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

methylnaltrexone

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 20, 2006
• Study Start: October 31, 2006
• Primary Completion: February 29, 2008
• Study Completion: February 29, 2008
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)