Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367548

Enrollment

Registered

2011-06-07

Start date

2003-07-31

Completion date

2004-12-31

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Brief summary

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

Interventions

DRUGIV Methylnaltrexone (MNTX)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Males and females, 18 yrs or older 2. Patients who have undergone a segmental colectomy 3. Must be receiving opioids via IV.

Exclusion criteria

1. Patients who received any experimental drug in the last 30 days 2. Patients receiving spinal medication for post-operative pain relief 3. Patients who have undergone operations for complications related to inflammatory bowel disease 4. Patients with recent history of abdominal radiation therapy.

Design outcomes

Primary

Measure	Time frame	Description
Time to tolerance of liquids	7 days	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

Secondary

Measure	Time frame	Description
Time to first bowel movement	7 days	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Time to tolerance of solid foods	7 days	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Time to first micturition post foley catheter removal	7 days	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.
Time to hospital discharge	7 days	To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026