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

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ClinicalTrials.gov Identifier: NCT01360372
Recruitment Status : Withdrawn (No eligible subjects identified)
First Posted : May 25, 2011
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Michael Sherman, 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.

Condition or disease Intervention/treatment Phase
Tube Feeding Drug: Methylnaltrexone Drug: Saline injection Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
Study Start Date : October 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Methylnaltrexone Drug: Methylnaltrexone
Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight
Placebo Comparator: saline placebo injection Drug: Saline injection
Saline 0.4 to 0.8 ml injection



Primary Outcome Measures :
  1. Hydrogen breath test measure of bowel transit [ Time Frame: 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 :
  1. Gastric residual volume measurement [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360372


Locations
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Cancer Treatment Center of America
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University
Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Michael Sherman, MD PI, Drexel University
ClinicalTrials.gov Identifier: NCT01360372     History of Changes
Other Study ID Numbers: Drexel18538
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Michael Sherman, Drexel University:
Hydrogen breath test value and gastric residual volume measurements
Tube feeding tolerance while taking a stable dose of opiate

Additional relevant MeSH terms:
Opiate Alkaloids
Methylnaltrexone
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists