Phase 3
Completed N=524
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Post-Operative Ileus (POI)
Source: ClinicalTrials.gov NCT00401375 ↗
Enrolled (actual)
524
Serious AEs
18.8%
Results posted
Sep 2019
Primary outcomePrimary: Time to First Bowel Movement — 4.4; 4.8; 4.6 days — p=0.4259
◆ Published Evidence
Established
68citations · ~5 / year
Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials.
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.
Linked Publications
-
Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00401375) and the linked publication. 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. Informational only — not medical advice.