Colon Prep for Colonoscopy
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.
Interventions
DRUGECP Colon Prep Kit
ECP Colon Prep Kit
DRUGMoviPrep®
MoviPrep®
Sponsors
Sebela Pharmaceuticals Development LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Scheduled to undergo a medically indicated colonoscopy for colorectal cancer screening or surveillance for colorectal cancer * Females must be non-lactating and have a negative pregnancy test if of child bearing potential * Ability and willingness of subject to participate fully in all aspects of this clinical trial * Written informed consent
Exclusion criteria
* Known or suspected clinically significant intestinal stricture of any etiology * History of diabetes mellitus, controlled with insulin * Taking insulin by injection * Pregnant or lactating * Renal insufficiency, hypokalemia, hyperkalemia, chronic liver disease or arrhythmic disorder * Chronic heart failure or recent (within 90 days of screening) acute heart failure * Receiving warfarin, heparin, clopidogrel, Pradaxa®, Xarelto®, Effient® or other blood thinning agents * Short bowel syndrome * Known diagnosis of Crohn's disease or ulcerative colitis, exclusionary only if subject has a history of any bowel resection, has suspected active inflammation, has symptoms suggestive of obstruction or a known bowel stricture * Severe psychological disease causing functional impairment limiting capacity to complete the preparation * Impaired consciousness increasing the risk of aspiration * Used narcotics/opiates within the 14 days prior to the colonoscopy * Used an anti-diarrheal within the 14 days prior to the colonoscopy procedure * Uses drugs of abuse including abused prescription medication * Used iron supplements within 14 days of the colonoscopy procedure * History of gastrointestinal surgery other than appendectomy or cholecystectomy * Diagnosis of gastroparesis or ileus * Symptoms of chronic constipation defined as fewer than 3 bowel movements per week on average over the previous 3 months * History of a failed bowel preparation, defined as either requiring an enema the day of the colonoscopy or needing to have the colonoscopy repeated * CTCAE grade 1 sodium, potassium or magnesium at screening * Clinically significant abnormalities (ketones, protein, glucose) at screening urinalysis, in the opinion of the investigator * Any known allergies to any of the ingredients or ECP Colon Prep Kit (including coconut) or the active comparator * Unable or unwilling to consume all components of the study drug including aversions to or adverse events from flavoring * Received any investigational therapy within 30 days of initiation of study drug * Serious underlying disease that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study * Requirement to use chromoendoscopy during the procedure for the purpose of surveillance for colorectal dysplasia or cancer in subjects with inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with successful bowel cleansing defined as centrally read 4 point modified Aronchick Scale (1=Inadequate, 2=Fair, 3=Good, 4=Excellent) score of either good or excellent. | 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure. |
Countries
United States
Outcome results
None listed