Safety and Efficacy Study of an Edible Colonoscopy Preparation

Sebela Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Colon Prep for Colonoscopy

Treatments: Drug: MoviPrep®; Drug: ECP Colon Prep Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT03332485

SEB-ECP-202

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

ECP Colon Prep Kit

Experimental group

Treatment:

Drug: ECP Colon Prep Kit

MoviPrep®

Active Comparator group

Treatment:

Drug: MoviPrep®