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

Drexel University

Status and phase: Withdrawn; Phase 3

Conditions: Tube Feeding

Treatments: Drug: Saline injection; Drug: Methylnaltrexone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01360372

Drexel18538

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Methylnaltrexone

Active Comparator group

Treatment:

Drug: Methylnaltrexone

saline placebo injection

Placebo Comparator group

Treatment:

Drug: Saline injection