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NCT03815019 · ClinicalTrials.gov registry record · Phase 4
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
A Phase 4 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT03815019: Completed Phase 4 study, sponsored by University of Kansas Medical Center.
NCT03815019 is a Phase 4 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815019, a Phase 4 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).
Primary Outcome
The efficacy of megestrol as part of the 24 week iKanEat protocol will be measured by participants who successfully transitioned to oral feeding, defined at at least 90% calories consumed orally.
Interventions
- DRUG Megestrol Acetate
- BEHAVIORAL iKanEat Behavioral Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 4 |
What the finished NCT03815019 record still lists
NCT03815019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Megestrol Acetate is the first listed.
NCT03815019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815019 about?
NCT03815019 is a clinical study titled "iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children". This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric populatio...
What is the current status of trial NCT03815019?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2019-08-15. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT03815019?
The interventions under investigation include: Megestrol Acetate (DRUG), iKanEat Behavioral Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03815019?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815019's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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