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

Tube Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01360372
• Other study ID #: Drexel18538
• Status: Withdrawn
• Phase: Phase 3
• First received: March 16, 2011
• Last updated: March 10, 2015
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tube Feeding

Intervention

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
• Saline injection
Saline 0.4 to 0.8 ml injection

Locations

Country	Name	City	State
United States	Cancer Treatment Center of America	Philadelphia	Pennsylvania
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrogen breath test measure of bowel transit	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.	2 days	No
Secondary	Gastric residual volume measurement	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.	3 days	No