Overview

Comparison of Clenpiq vs Golytely Bowel Preparation

Status:
Terminated
Trial end date:
2019-03-26
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Collaborator:
Ferring Pharmaceuticals
Treatments:
Citric Acid
Magnesium Oxide
Picosulfate sodium
Polyethylene glycol 3350
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)