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CLINICAL TRIALS PROFILE FOR MIRALAX

Clinical Trials for Miralax

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00319670	A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children	Completed	Braintree Laboratories	Phase 4	To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
NCT00889655	A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely	Unknown status	Oregon Health and Science University	Phase 4	Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.
NCT00953017	A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy	Completed	Brooke Army Medical Center	Phase 4	Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.
NCT01028573	A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy	Unknown status	Southern California Institute for Research and Education	N/A	The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.
NCT01063049	Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation	Completed	Gastroenterology Services, Ltd.	Phase 4	The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.
NCT01140295	Bowel Preparation for Colonoscopy in Children	Terminated	Children's Hospital of Philadelphia	Phase 4	The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
NCT01170754	Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy	Completed	Temple University	Phase 4	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.
Trial ID	Title	Status	Sponsor	Phase	Summary