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

This study has been withdrawn prior to enrollment.
(No eligible subjects identified)
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Michael Sherman, Drexel University
ClinicalTrials.gov Identifier:
NCT01360372
First received: March 16, 2011
Last updated: March 10, 2015
Last verified: March 2015

March 16, 2011
March 10, 2015
October 2010
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01360372 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Tube Feeding
  • 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
  • Drug: Saline injection
    Saline 0.4 to 0.8 ml injection
  • Active Comparator: Methylnaltrexone
    Intervention: Drug: Methylnaltrexone
  • Placebo Comparator: saline placebo injection
    Intervention: Drug: Saline injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01360372
Drexel18538
Yes
Michael Sherman, Drexel University
Drexel University
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Drexel University
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP