Safety and Tolerability Study of an Edible Colon Preparation
Information source: ColonaryConcepts LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bowel Preparation
Intervention: NuLYTELY® (PEG 3350) (Drug); ECP-019 (Drug); MoviPrep® (PEG 3350) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: ColonaryConcepts LLC Official(s) and/or principal investigator(s): Karl Gallegos, MD, Study Director, Affiliation: Not Affiliated
Overall contact: Shelley Huneven, Phone: 603-504-2197, Email: info@colonaryconcepts.com
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
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
Primary outcome: The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
Secondary outcome: Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
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.
- For women of child bearing potential, a negative pregnancy test.
- Patients who are willing and able to comply with study procedures.
- Documentation of informed consent by the use of a written consent form approved by
the IRB and signed and dated by the patient.
Exclusion Criteria:
- Known intestinal stricture of any etiology.
- History of diabetes mellitus.
- Pregnancy.
- Patients with renal insufficiency defined as a Cr >2. 0 or a history of hypo- or
hyperkalemia, chronic liver disease, congestive heart failure, or arrhythmic disorder
(i. e., higher risk of complications from electrolyte abnormalities than healthy
patients).
- Patients being treated with warfarin, heparin (standard or low molecular weight
heparin) or clopidogrel, Pradaxa®, Xarelto®, Effient® or other anticoagulant agents.
- Previous history of inadequate preparation for a colonoscopy.
- Patients with a history of colonic resection, Crohn's disease, or ulcerative colitis.
- Severe psychological disease causing functional impairment limiting capacity to
complete the preparation.
- Use of narcotics/opiates within 2 weeks prior to the procedure.
- Use of anti-diarrheal within 2 weeks prior to the procedure.
- Use of drugs of abuse, including abused prescription medications.
- Use of iron oral supplements within 2 weeks of the procedure.
- Previous gastrointestinal surgery.
- A known diagnosis of gastroparesis.
- Symptoms of chronic constipation defined as fewer than three bowel movements per-week
on average over the previous 3 months.
- Clinically significant laboratory abnormalities as judged by the study investigator
from blood tests drawn at Screening study visit.
- Patients with any known allergies to the ingredients of the test products (aspartame,
gluten, lactose, milk, peanuts, sesame, soy, tree nuts, or wheat) or comparator
products.
- Patients with phenylketonuria (PKU) or a known sensitivity to the artificial
sweetener called aspartame.
Locations and Contacts
Shelley Huneven, Phone: 603-504-2197, Email: info@colonaryconcepts.com
Indiana University, Indianapolis, Indiana 46290, United States; Recruiting Douglas K. Rex, MD, Phone: 317-948-8741, Email: drex@iu.edu
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting Jessica I Chevalier, Phone: 603-653-9033, Email: Jessica.I.Chevalier@Hitchcock.org
Additional Information
Starting date: May 2015
Last updated: May 18, 2015
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