The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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.
United States: Food and Drug Administration
|Hahnemann University Hospital||Philadelphia, Pennsylvania 19102-1192|
|Cancer Treatment Center of America||Philadelphia, Pennsylvania 19124|