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NCT02435069 · ClinicalTrials.gov registry record · Phase 4
A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
A Phase 4 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT02435069: Completed Phase 4 study, sponsored by Nemours Children's Clinic.
NCT02435069 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02435069, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
There is a surgical procedure to help children with intractable fecal incontinence gain continence for stool through construction of a tube that connects the abdominal wall to the colon near or through the appendix. This tube allows easy administration of enema solution into the first part of the colon. Putting enema solution through that tube into the colon is called an antegrade continence enema (ACE) and has been shown to work well in helping some but not all children prevent stool accidents. The purpose of this study is to compare a large volume ACE flush using a salt water solution called normal saline with a small volume ACE flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose and flush frequency of each solution needed to prevent stool accidents; 2) compare which solution given at the best dose has the least side effects and 3) to determine if administration of either of the ACE flushing solutions causes electrolyte abnormalities or affects colon health.
Primary Outcome
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on
Interventions
- DRUG Dose Response - NS and USP Glycerin - First Intervention
- DRUG Effectiveness - NS and USP Glycerin - Second Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-02-09 |
| Est. Completion | 2018-03-30 |
| Phase | Phase 4 |
What the finished NCT02435069 record still lists
NCT02435069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Dose Response - NS and USP Glycerin - First Intervention is the first listed.
NCT02435069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02435069 about?
NCT02435069 is a clinical study titled "A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children". There is a surgical procedure to help children with intractable fecal incontinence gain continence for stool through construction of a tube that connects the abdominal wall to the colon near or through the appendix. This tube allows easy administration of enema solution into the first part of the co...
What is the current status of trial NCT02435069?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2016-02-09. Estimated completion is 2018-03-30.
What interventions are being tested in trial NCT02435069?
The interventions under investigation include: Dose Response - NS and USP Glycerin - First Intervention (DRUG), Effectiveness - NS and USP Glycerin - Second Intervention (DRUG).
Who is sponsoring clinical trial NCT02435069?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02435069's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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