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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

Tracking Information
First Submitted Date  ICMJE March 25, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date January 29, 2018
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)		 The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)		 Percentage of patients who completed each of the ECP-019 formulation/dosing regimens [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of an Edible Colon Preparation
Official Title  ICMJE 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.
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Bowel Preparation
Intervention  ICMJE
  • Drug: NuLYTELY® (PEG 3350)
  • Drug: ECP-019
  • Drug: MoviPrep® (PEG 3350)
Study Arms  ICMJE
  • Experimental: ECP-019 A (Group A)
    Intervention: Drug: ECP-019
  • Experimental: ECP-019 B (Group B)
    Intervention: Drug: ECP-019
  • Experimental: ECP-019 C (Group C)
    Intervention: Drug: ECP-019
  • Active Comparator: Group D
    Intervention: Drug: MoviPrep® (PEG 3350)
  • Active Comparator: Group E
    Intervention: Drug: NuLYTELY® (PEG 3350)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2017)		 69
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)		 110
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02402270
Other Study ID Numbers  ICMJE ECP-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ColonaryConcepts LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ColonaryConcepts LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ColonaryConcepts LLC
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP