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

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Postoperative Ileus

Treatments: Drug: IV Methylnaltrexone (MNTX); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367548

MNTX 203

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: IV Methylnaltrexone (MNTX)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo