Clinical trial NCT03332485: Safety and Efficacy Study of an Edible Colonoscopy Preparation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Prep for Colonoscopy
Lead sponsor: Sebela Pharmaceuticals Development LLC
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Sebela Site 007
state: California
city: Indianapolis
country: United States
facility: Sebela Site 006
state: Indiana
city: Bastrop
country: United States
facility: Sebela Site 002
state: Louisiana
city: Annapolis
country: United States
facility: Sebela Site 003
state: Maryland
city: Great Neck
country: United States
facility: Sebela Site 004
state: New York
city: Wilmington
country: United States
facility: Sebela Site 008
state: North Carolina
city: Mentor
country: United States
facility: Sebela Site 001
state: Ohio
city: Ogden
country: United States
facility: Sebela Site 005
state: Utah
Study officials:
affiliation: Sebela Pharmaceuticals Development LLC
name: Sue Hall
role: STUDY_DIRECTOR
References: