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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This study has been withdrawn prior to enrollment.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:
Drexel University
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
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | March 16, 2011 | ||
| Last Updated Date | March 10, 2015 | ||
| Start Date ICMJE | October 2010 | ||
| Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Hydrogen breath test measure of bowel transit [ Time Frame: 2 days ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT01360372 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
Gastric residual volume measurement [ Time Frame: 3 days ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates | ||
| Official Title ICMJE | The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy | ||
| Brief 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. | ||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Tube Feeding | ||
| Intervention ICMJE |
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| Study Arms |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Withdrawn | ||
| Enrollment ICMJE | 0 | ||
| Completion Date | May 2012 | ||
| Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01360372 | ||
| Other Study ID Numbers ICMJE | Drexel18538 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | Not Provided | ||
| Responsible Party | Michael Sherman, Drexel University | ||
| Study Sponsor ICMJE | Drexel University | ||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Drexel University | ||
| Verification Date | March 2015 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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