Safety and Efficacy Study of an Edible Colonoscopy Preparation

• Status: Completed
• Trial end date: 2018-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sebela Pharmaceuticals Development LLC
• Treatments: Polyethylene glycol 3350

Criteria

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