Safety and Efficacy Study of an Edible Colonoscopy Preparation

NCT03332485 | Completed Phase 2 FDA Drug

• 1 other identifier: SEB-ECP-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

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.

Conditions

Colon Prep for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ECP Colon Prep Kit

EXPERIMENTAL

Drug: ECP Colon Prep Kit

MoviPrep®

ACTIVE COMPARATOR

Drug: MoviPrep®

Interventions

ECP Colon Prep Kit DRUG

ECP Colon Prep Kit

ECP Colon Prep Kit

MoviPrep® DRUG

MoviPrep®

MoviPrep®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Sebela Pharmaceuticals Development LLC: lead

Study Sites (8)

Sebela Site 007

Anaheim, California, 92801, United States

Location

Sebela Site 006

Indianapolis, Indiana, 46202, United States

Location

Sebela Site 002

Bastrop, Louisiana, 71220, United States

Location

Sebela Site 003

Annapolis, Maryland, 21401, United States

Location

Sebela Site 004

Great Neck, New York, 11023, United States

Location

Sebela Site 008

Wilmington, North Carolina, 28403, United States

Location

Sebela Site 001

Mentor, Ohio, 44060, United States

Location

Sebela Site 005

Ogden, Utah, 84405, United States

Location

MeSH Terms

Interventions

MoviPrep

Study Officials

• Sue Hall

  Sebela Pharmaceuticals Development LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: November 20, 2017
• Primary Completion: March 14, 2018
• Study Completion: March 14, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

US (8)