Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates

Tracking Information
First Submitted Date ICMJE	March 16, 2011
First Posted Date ICMJE	May 25, 2011
Last Update Posted Date	March 17, 2015
Study Start Date ICMJE	October 2010
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 24, 2011)	Hydrogen breath test measure of bowel transit [ Time Frame: 2 days ]; 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01360372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 24, 2011)	Gastric residual volume measurement [ Time Frame: 3 days ]; 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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
Official Title ICMJE	The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Tube Feeding
Intervention ICMJE	Drug: 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; Drug: Saline injection Saline 0.4 to 0.8 ml injection
Study Arms	Active Comparator: Methylnaltrexone Intervention: Drug: Methylnaltrexone; Placebo Comparator: saline placebo injection Intervention: Drug: Saline injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: March 10, 2015)	0
Original Estimated Enrollment ICMJE; (submitted: May 24, 2011)	40
Actual Study Completion Date	May 2012
Actual Primary Completion Date	May 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Inadequate tube feeding rate of greater than equal to 40% below goal rate.; Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours; Stable dose or no dose laxative for minimum 72 hours Exclusion Criteria: Unstable Hemodynamics (eg. vasopressor medication); Pregnancy; End stage Renal Disease on Dialysis; Plan to wean opiates in next 48 hours; Known or suspected mechanical gastrointestinal obstruction; Initial expired hydrogen breath level greater than 20
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01360372
Other Study ID Numbers ICMJE	Drexel18538
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Michael Sherman, Drexel University
Study Sponsor ICMJE	Drexel University
Collaborators ICMJE	Wyeth is now a wholly owned subsidiary of Pfizer
Investigators ICMJE	Not Provided
PRS Account	Drexel University
Verification Date	March 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP