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NCT03410524 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy
A Phase 3 study, sponsored by University of Nevada, Reno.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT03410524: Completed Phase 3 study, sponsored by University of Nevada, Reno.
NCT03410524 is a Phase 3 study that has completed, run by University of Nevada, Reno. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03410524, a Phase 3 study, has completed, sponsored by University of Nevada, Reno.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new research. In 2006, 3 medical organizations recommended the use of polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution was commonly used using a split dose regimen for bowel prep. However, many patients found that this large volume gave them side effects including bloating and cramping. Other studies showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy of bowel preparation. With the institution of lower volume PEG preparation our offices noted improved patient toleration, satisfaction, and clinical outcomes. However, multiple endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume preparation. This can impair proper visualization of the bowel wall even with an adequate bowel preparation. The current standard of practice includes irrigation, lavage, and suctioning using a simethicone infused saline during the colonoscopy. Its property of reducing surface tension to help dissolve bubbles and clear the field of view is vital during the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is considered rather safe. This study evaluates whether the addition of oral simethicone with the colonoscopy bowel preparation reduces bubbles and foam during the procedure using a randomized and controlled interventional study.
Primary Outcome
I \>90% of the mucosal circumference seen II 90%-75% of the mucosal seen without foam or bubbles not requiring irrigation III 74% to 50% of the mucosa is free of foam or bubbles. Required irrigation IV \<50% of the mucosa seen free of foam or bubbles. Required irrigation
Interventions
- DRUG Water
- DRUG Simethicone Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 3 |
What the finished NCT03410524 record still lists
NCT03410524 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Water is the first listed.
NCT03410524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03410524 about?
NCT03410524 is a clinical study titled "Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy". An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new re...
What is the current status of trial NCT03410524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2018-01-09. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03410524?
The interventions under investigation include: Water (DRUG), Simethicone Solution (DRUG).
Who is sponsoring clinical trial NCT03410524?
This trial is sponsored by University of Nevada, Reno, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03410524's enrollment target sits among peer trials
250 1249th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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