NCT01360372

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

March 16, 2011

Last Update Submit

March 10, 2015

Conditions

Tube Feeding

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Hydrogen breath test measure of bowel transit

    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.

    2 days

Secondary Outcomes (1)

  • Gastric residual volume measurement

    3 days

Study Arms (2)

Methylnaltrexone

ACTIVE COMPARATOR
Drug: Methylnaltrexone

saline placebo injection

PLACEBO COMPARATOR
Drug: Saline injection

Interventions

MethylnaltrexoneDRUG

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

Methylnaltrexone
Saline injectionDRUG

Saline 0.4 to 0.8 ml injection

saline placebo injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Cancer Treatment Center of America

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Interventions

methylnaltrexoneSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PI

Study Record Dates

First Submitted

March 16, 2011

First Posted

May 25, 2011

Study Start

October 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(2)