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

MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00779649
Acronym
LUSTER
Enrollment
220
Registered
2008-10-24
Start date
2008-09-30
Completion date
2009-10-31
Last updated
2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

Colonoscopy,, Prep, MoviPrep, HalfLytely, The effectiveness of colonoscopy preps

Brief summary

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.

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

Interventions

OTHERMoviPrep 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.

OTHERHalfLytely 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

Sponsors

Research Associates of New York, LLP
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Has provided written informed consent. 2. Is scheduled for colonoscopy within 30 days of screening 3. 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 4. Is able to communicate effectively with study personnel.

Exclusion criteria

1. 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. 2. 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. 3. History of renal insufficiency

Design outcomes

Primary

MeasureTime frame
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.one year from the trial start date

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026