Safety and Efficacy Study of an Edible Colonoscopy Preparation

March 15, 2018 updated by: Sebela Pharmaceuticals Development LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.
24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sebela Pharmaceuticals Development LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sue Hall, Sebela Pharmaceuticals Development LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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