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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Drexel University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT01360372
First received: March 16, 2011
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Tube Feeding
Drug: Methylnaltrexone
Drug: Saline injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Hydrogen breath test measure of bowel transit [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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:
  • Gastric residual volume measurement [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360372

Contacts
Contact: Mary P Hendry, MS, RN 215 762 7499 mhendry@drexelmed.edu
Contact: Michael S Sherman, MD 215 762 7013 msherman@drexelmed.edu

Locations
United States, Pennsylvania
Hahnemann University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Mary P Hendry, MS, RN    215-762-7499    mhendry@drexelmed.edu   
Principal Investigator: Michael S Sherman, MD         
Cancer Treatment Center of America Not yet recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Jeffrey B Hoag, MD    215-762-7011    jhoag@drexelmed.edu   
Principal Investigator: Jeffrey B Hoag, MD         
Sponsors and Collaborators
Drexel University
Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Michael Sherman, MD, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT01360372     History of Changes
Other Study ID Numbers: Drexel18538
Study First Received: March 16, 2011
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014