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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01360372
Other study ID # Drexel18538
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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