MoviPrep� Versus HalfLytely�, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial
Information source: Research Associates of New York, LLP
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: MoviPrep Kit (Other); HalfLytely and Bisacodyl Tablets Bowel Prep Kit (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Research Associates of New York, LLP Official(s) and/or principal investigator(s):
Lawrence B Cohen, MD, Principal Investigator, Affiliation: New York Gastroenterology Associates, L.L.P
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.
Clinical Details
Official title: MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: September 2008
Last updated: October 29, 2009
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