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The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Tube Feeding

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Trial Information

The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Hydrogen breath test measure of bowel transit

Outcome Description:

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.

Outcome Time Frame:

2 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

Drexel18538

NCT ID:

NCT01360372

Start Date:

October 2010

Completion Date:

January 2012

Related Keywords:

  • Tube Feeding
  • Hydrogen breath test value and gastric residual volume measurements
  • Tube feeding tolerance while taking a stable dose of opiate

Name

Location
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
Cancer Treatment Center of America Philadelphia, Pennsylvania  19124