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

Phase 3

Withdrawn

• Conditions: Tube Feeding
• Interventions: Drug: Methylnaltrexone; Drug: Saline injection

• Registration Number: NCT01360372
• Lead Sponsor: Drexel University

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylnaltrexone	Methylnaltrexone	-
saline placebo injection	Saline injection	-

Primary Outcome Measures

Name	Time	Method
Hydrogen breath test measure of bowel transit	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.

Secondary Outcome Measures

Name	Time	Method
Gastric residual volume measurement	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.

Trial Locations

Locations (2)

Cancer Treatment Center of America; 🇺🇸 Philadelphia, Pennsylvania, United States

Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States