Status:
COMPLETED
Safety and Efficacy Study of an Edible Colonoscopy Preparation
Lead Sponsor:
Sebela Pharmaceuticals Development LLC
Conditions:
Colon Prep for Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03332485
Start Date
November 20 2017
End Date
March 14 2018
Last Update
March 19 2018
Active Locations (8)
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1
Sebela Site 007
Anaheim, California, United States, 92801
2
Sebela Site 006
Indianapolis, Indiana, United States, 46202
3
Sebela Site 002
Bastrop, Louisiana, United States, 71220
4
Sebela Site 003
Annapolis, Maryland, United States, 21401