Phase 3 N=524 Randomized Quadruple-blind Treatment

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

Post-Operative Ileus (POI)

Bottom Line

View on ClinicalTrials.gov: NCT00401375 ↗

Enrolled (actual)

524

Serious AEs

18.8%

Results posted

Sep 2019

Primary outcome: Primary: Time to First Bowel Movement — 4.4; 4.8; 4.6 days — p=0.4259

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Methylnaltrexone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Bowel Movement	4.4; 4.8; 4.6	0.4259
SECONDARY Time to Discharge Eligibility	5.8; 7.0; 6.5	—
SECONDARY Time to Discharge Order Written From the End of Surgery	6.8; 9.1; 7.3	—
SECONDARY 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)	13; 12; 17; 9; 4; 5	—

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.

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.

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Data sourced from ClinicalTrials.gov (NCT00401375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.