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WITHDRAWNPhase 3NCT01360372

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

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.

Lead sponsor: Drexel University•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Drexel University

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 17, 2015Terms

Trial snapshot

StatusWITHDRAWN

PhasePHASE3

Enrollment—

Start dateOct 2010

Last updatedMar 17, 2015

Condition

Locations shown

Hahnemann University Hospital

Philadelphia, Pennsylvania

Cancer Treatment Center of America

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2015Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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