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NCT01170754 · ClinicalTrials.gov registry record · Phase 4
Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy
A Phase 4 study, sponsored by Temple University.
- Completed
- Registry status
- Phase 4
- Development phase
- 136
- Enrollment target
NCT01170754 is a Phase 4 study that has completed, run by Temple University. The registered enrollment target is 136 participants.
The verdict
NCT01170754, a Phase 4 study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 136 participants
- Enrollment target
Study Summary
A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely) has been used for over two decades for colon cleansing. The mixture is not very palatable due to the electrolyte additives which include sodium sulfate. To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done with this prep. Anecdotally there have been reports (case series) that it is far more palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is not surprising. The issue at present is that there has never been a blinded study to confirm these claims. This study will compare the efficacy of the two preps. There is no funding. The investigators will charge insurance companies for the prep - this is our current practice. The procedures will be done on healthy individuals referred for colon cancer screening and the exam will be billed to their insurance. There will be no patient honorarium. The investigators will check electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.
Interventions
- DRUG PEG-3350 and Gatorade
- DRUG Golytely 4 liters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01170754
The ClinicalTrials.gov registry entry for NCT01170754 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PEG-3350 and Gatorade is the first listed.
NCT01170754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01170754 about?
NCT01170754 is a clinical study titled "Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy". A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) m...
What is the current status of trial NCT01170754?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 136 participants. The study started on 2010-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01170754?
The interventions under investigation include: PEG-3350 and Gatorade (DRUG), Golytely 4 liters (DRUG).
Who is sponsoring clinical trial NCT01170754?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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