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

The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01360372

Enrollment

Registered

2011-05-25

Start date

2010-10-31

Completion date

2012-05-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tube Feeding

Keywords

Hydrogen breath test value and gastric residual volume measurements, Tube feeding tolerance while taking a stable dose of opiate

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.

Interventions

DRUGMethylnaltrexone

Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight

DRUGSaline injection

Saline 0.4 to 0.8 ml injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026