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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 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02435069
The ClinicalTrials.gov registry entry for NCT02435069 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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