Safety and Efficacy Study of an Edible Colonoscopy Preparation

A Randomized, Investigator- and Colonoscopist-blinded, Phase 2 Study of the Efficacy and Safety of ECP (Polyethylene Glycol 3350 [PEG 3350]) Colon Prep Kit Compared With MoviPrep® Split-dose for Colonoscopy Preparation

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.

Study Overview

• Status: Completed
• Conditions: Colon Prep for Colonoscopy
• Intervention / Treatment: Drug: ECP Colon Prep Kit; Drug: MoviPrep®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Sebela Site 007
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Sebela Site 006
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Sebela Site 002
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Sebela Site 003
  • New York
    • Great Neck, New York, United States, 11023
      • Sebela Site 004
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Sebela Site 008
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Sebela Site 001
  • Utah
    • Ogden, Utah, United States, 84405
      • Sebela Site 005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECP Colon Prep Kit	Drug: ECP Colon Prep Kit; ECP Colon Prep Kit
Active Comparator: MoviPrep®	Drug: MoviPrep®; MoviPrep®

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Sebela Pharmaceuticals Development LLC
• Investigators: Study Director: Sue Hall, Sebela Pharmaceuticals Development LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): March 14, 2018

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SEB-ECP-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No