MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial - Full Text View

Sponsored by:	Research Associates of New York, LLP
Information provided by:	Research Associates of New York, LLP
ClinicalTrials.gov Identifier:	NCT00779649

Purpose

A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.

Condition	Intervention	Phase
Colonoscopy	Other: MoviPrep Kit Other: HalfLytely and Bisacodyl Tablets Bowel Prep Kit	Phase IV

Drug Information available for: Amphetamine Methamphetamine Bisacodyl Bisacodyl tannex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-Blinded, Randomized Trial.

Further study details as provided by Research Associates of New York, LLP:

Primary Outcome Measures:

The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire. [ Time Frame: one year from the trial start date ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	September 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MoviPrep: Active Comparator	Other: MoviPrep Kit Diet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure. Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption.
HalfLytely: Active Comparator	Other: HalfLytely and Bisacodyl Tablets Bowel Prep Kit Diet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed. Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed

Arms

Assigned Interventions

MoviPrep: Active Comparator

Other: MoviPrep Kit

Diet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure.

Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption.

HalfLytely: Active Comparator

Other: HalfLytely and Bisacodyl Tablets Bowel Prep Kit

Diet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed.

Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed

Detailed Description:

To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing colonoscopy

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Has provided written informed consent.
Is scheduled for colonoscopy within 30 days of screening
Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
Is able to communicate effectively with study personnel.

Exclusion Criteria:

Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
History of renal insufficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779649

Contacts

Contact: Lawrence B Cohen, MD	212-996-6633	Lawrence.Cohen@nyga.md
Contact: Lyn Santiago, RN	212-996-5959	lyn.santiago@nyga.md

Locations

United States, New York
New York Gastroenterology Associates, L.L.P.	Recruiting
New York, New York, United States, 10021
Contact: Lyn Santiago, RN 212-996-1105 rany@nyga.md

Sponsors and Collaborators

Research Associates of New York, LLP

Investigators

Principal Investigator:

Lawrence B Cohen, MD

New York Gastroenterology Associates, L.L.P

More Information

Responsible Party:	Research Associates of New York ( Lawrence B Cohen, MD )
Study ID Numbers:	LUSTER
Study First Received:	October 22, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779649
Health Authority:	United States: Institutional Review Board

Keywords provided by Research Associates of New York, LLP:

Colonoscopy,
Prep
MoviPrep
HalfLytely
The effectiveness of colonoscopy preps

Study placed in the following topic categories:

Methamphetamine
Amphetamine
Bisacodyl

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Cathartics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009