Clinical trial NCT03198221: Comparison of Clenpiq vs Golytely Bowel Preparation
Official title: Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Versus Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bowel Preparation Solutions
Keywords: Golytely, Clenpiq, bowel prep
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2017-06-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be receive either Golytely or Clenpiq bowel prep solutions. Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the colonoscopy procedure.
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.

Detailed description: The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation.

Eligibility criteria: Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

* Creatinine clearance less than 30 ml/min
* History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
* Small bowel obstruction, ileus or bowel perforation
* Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
* Gastroparesis
* Toxic megacolon or undergoing colonoscopy for decompression
* Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
* History of prior colorectal surgery
* Allergy to any of the ingredients in Clenpiq or golytely
* if the procedure is planned in the intensive care unit (ICU)

Primary outcomes:
measure: Percentage of Participants With Satisfactory Bowel Cleansing
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of Participants Requiring a Repeat Colonoscopy
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Carol Burke, MD
role: PRINCIPAL_INVESTIGATOR
References: