Safety and Efficacy Study of an Edible Colonoscopy Preparation

Phase 2

Completed

• Conditions: Colon Prep for Colonoscopy
• Interventions: Drug: MoviPrep®; Drug: ECP Colon Prep Kit

• Registration Number: NCT03332485
• Lead Sponsor: Sebela Pharmaceuticals Development LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-11-20
• Status Verified: 2018-03
• Primary Completion: 2018-03-14
• Study Completion: 2018-03-14
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MoviPrep®	MoviPrep®	-
ECP Colon Prep Kit	ECP Colon Prep Kit	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Sebela Site 006; 🇺🇸 Indianapolis, Indiana, United States

Sebela Site 001; 🇺🇸 Mentor, Ohio, 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 002; 🇺🇸 Bastrop, Louisiana, United States

Sebela Site 005; 🇺🇸 Ogden, Utah, United States

Sebela Site 007; 🇺🇸 Anaheim, California, United States