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

• Status: Withdrawn
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drexel University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Methylnaltrexone; Naltrexone

Criteria

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