Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy|
- Hydrogen breath test measure of bowel transit [ Time Frame: 2 days ] [ Designated as safety issue: No ]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.
- Gastric residual volume measurement [ Time Frame: 3 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Methylnaltrexone||
Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight
|Placebo Comparator: saline placebo injection||
Drug: Saline injection
Saline 0.4 to 0.8 ml injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360372
|Contact: Mary P Hendry, MS, RN||215 762 firstname.lastname@example.org|
|Contact: Michael S Sherman, MD||215 762 email@example.com|
|United States, Pennsylvania|
|Hahnemann University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19102|
|Contact: Mary P Hendry, MS, RN 215-762-7499 firstname.lastname@example.org|
|Principal Investigator: Michael S Sherman, MD|
|Cancer Treatment Center of America||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19124|
|Contact: Jeffrey B Hoag, MD 215-762-7011 email@example.com|
|Principal Investigator: Jeffrey B Hoag, MD|