Safety and Efficacy Study of an Edible Colonoscopy Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability Study of an Edible Colon Preparation

NCT02402270

Bowel Preparation

COMPLETED PHASE2

A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

NCT03404401

Colonoscopy

COMPLETED PHASE3

Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy

NCT03247595

Colonoscopy

COMPLETED NA

Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy

NCT01610856

Colonoscopy Preparation

COMPLETED NA

Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

NCT01093274

Bowel Preparation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Prep for Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ECP Colon Prep Kit

Group Type EXPERIMENTAL

ECP Colon Prep Kit

Intervention Type DRUG

ECP Colon Prep Kit

MoviPrep®

Group Type ACTIVE_COMPARATOR

MoviPrep®

Intervention Type DRUG

MoviPrep®

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECP Colon Prep Kit

Intervention Type DRUG

MoviPrep®

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes