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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Methylnaltrexone (MNTX) | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals, Inc. | Tarrytown | New York | 10591 | United States |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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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 |