Safety and Efficacy Study of an Edible Colonoscopy Preparation

Completed · Phase 2

Conditions studied: Colon Prep for Colonoscopy

In brief

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.

Key facts

Study ID

NCT03332485

Run by

Sebela Pharmaceuticals Development LLC

People needed

60

Starts

2017-11-20

Expected to finish

2018-03-14

Last updated by the study team

2018-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sebela Site 007 — Anaheim, California, United States
• Sebela Site 006 — Indianapolis, Indiana, United States
• Sebela Site 002 — Bastrop, Louisiana, United States
• Sebela Site 003 — Annapolis, Maryland, United States
• Sebela Site 004 — Great Neck, New York, United States
• Sebela Site 008 — Wilmington, North Carolina, United States
• Sebela Site 001 — Mentor, Ohio, United States
• Sebela Site 005 — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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