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No eligible subjects identified
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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone | Active Comparator |
| |
| saline placebo injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug | Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hydrogen breath test measure of bowel transit | On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric residual volume measurement | Gastric residual volumes will be measured at baseline study entry and then every 4 hours throughout the study until 24 hours post study drug administration. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States | ||
| Cancer Treatment Center of America |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline injection | Drug | Saline 0.4 to 0.8 ml injection |
|
| Philadelphia |
| Pennsylvania |
| 19124 |
| United States |
| D017670 |
| Sodium Compounds |