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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: IV Methylnaltrexone (MNTX)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 yrs or older Patients who have undergone a segmental colectomy Must be receiving opioids via IV. Exclusion Criteria: Patients who received any experimental drug in the last 30 days Patients receiving spinal medication for post-operative pain relief Patients who have undergone operations for complications related to inflammatory bowel disease Patients with recent history of abdominal radiation therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: IV Methylnaltrexone (MNTX)<br> <br> |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tolerance of liquids | 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bowel movement | 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. | 7 days | 
| Time to tolerance of solid foods | 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. | 7 days | 
| Time to first micturition post foley catheter removal | 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. | 7 days | 
| Time to hospital discharge | 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. | 7 days |