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Safety and Efficacy Study of an Edible Colonoscopy Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03332485
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sebela Pharmaceuticals Development LLC

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.

Condition or disease Intervention/treatment Phase
Colon Prep for Colonoscopy Drug: ECP Colon Prep Kit Drug: MoviPrep® Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : March 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: MoviPrep

Arm Intervention/treatment
Experimental: ECP Colon Prep Kit Drug: ECP Colon Prep Kit
ECP Colon Prep Kit

Active Comparator: MoviPrep® Drug: MoviPrep®
MoviPrep®




Primary Outcome Measures :
  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. [ Time Frame: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332485


Locations
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United States, California
Sebela Site 007
Anaheim, California, United States, 92801
United States, Indiana
Sebela Site 006
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Sebela Site 002
Bastrop, Louisiana, United States, 71220
United States, Maryland
Sebela Site 003
Annapolis, Maryland, United States, 21401
United States, New York
Sebela Site 004
Great Neck, New York, United States, 11023
United States, North Carolina
Sebela Site 008
Wilmington, North Carolina, United States, 28403
United States, Ohio
Sebela Site 001
Mentor, Ohio, United States, 44060
United States, Utah
Sebela Site 005
Ogden, Utah, United States, 84405
Sponsors and Collaborators
Sebela Pharmaceuticals Development LLC
Investigators
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Study Director: Sue Hall Sebela Pharmaceuticals Development LLC
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Responsible Party: Sebela Pharmaceuticals Development LLC
ClinicalTrials.gov Identifier: NCT03332485    
Other Study ID Numbers: SEB-ECP-202
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No