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NCT01934192 · ClinicalTrials.gov registry record · Phase 2
Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT01934192 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 91 participants.
The verdict
NCT01934192, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gastric emptying in this population; and provide preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the Intensive Care Unit \[ICU\], time on ventilator, ICU acquired infections, and 60-day mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics upon repeat dosing in a critically ill population. After meeting eligibility criteria, male and female subjects will be randomized to either receive GSK962040 (50 milligram \[mg\]) once daily (OD) via naso-gastric (NG) or orogastric (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive), study treatments will switch such that those originally receiving GSK962040 will receive metoclopramide (10 mg, intravenous \[iv\], every 6 hours) and those subjects originally randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if subjects develop intolerance prior to any treatment, they will be randomized to receive either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours). The study will consist of a screening/baseline assessment, a treatment period (up to 7 days in duration), and a 4-day post treatment safety follow-up assessment. The duration of each subject's participation in the study from screening to follow-up safety assessment will be up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to the ICU.
Interventions
- DRUG Placebo IV
- DRUG GSK962040 50 mg
- DRUG Metoclopramide 10 mg
- DRUG Placebo NG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2014-04-04 |
| Est. Completion | 2016-07-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01934192
The ClinicalTrials.gov registry entry for NCT01934192 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo IV is the first listed.
NCT01934192 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01934192 about?
NCT01934192 is a clinical study titled "Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study". This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gas...
What is the current status of trial NCT01934192?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2014-04-04. Estimated completion is 2016-07-08.
What interventions are being tested in trial NCT01934192?
The interventions under investigation include: Placebo IV (DRUG), GSK962040 50 mg (DRUG), Metoclopramide 10 mg (DRUG), Placebo NG (DRUG).
Who is sponsoring clinical trial NCT01934192?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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