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Safety and Tolerability Study of an Edible Colon 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: NCT02402270
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
ColonaryConcepts LLC

Study Description
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Brief Summary:

The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.

In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.

Patients will be randomized (like flipping a coin) to one of five groups:

Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY


Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: NuLYTELY® (PEG 3350) Drug: ECP-019 Drug: MoviPrep® (PEG 3350) Phase 2

Detailed Description:
The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: ECP-019 A (Group A) Drug: ECP-019
Experimental: ECP-019 B (Group B) Drug: ECP-019
Experimental: ECP-019 C (Group C) Drug: ECP-019
Active Comparator: Group D Drug: MoviPrep® (PEG 3350)
Active Comparator: Group E Drug: NuLYTELY® (PEG 3350)


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Percentage of patients who completed each of the ECP-019 formulation/dosing regimens [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
  • Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.

Exclusion Criteria:

  • Known intestinal stricture of any etiology.
  • History of diabetes mellitus.
Contacts and Locations
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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): NCT02402270


Locations
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United States, Indiana
Indianapolis, Indiana, United States, 46290
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
ColonaryConcepts LLC
More Information
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Responsible Party: ColonaryConcepts LLC
ClinicalTrials.gov Identifier: NCT02402270    
Other Study ID Numbers: ECP-002
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Keywords provided by ColonaryConcepts LLC:
Colonoscopy
Preparation
Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents