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Comparison of Clenpiq vs Golytely Bowel Preparation

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ClinicalTrials.gov Identifier: NCT03198221
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Carol Burke, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Solutions Drug: Golytely Drug: Clenpiq Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Active Comparator: Group A
Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.
Drug: Golytely
bowel preparation
Other Name: polyethylene glycol 3350 and electrolytes oral solution

Active Comparator: Group B
Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Drug: Golytely
bowel preparation
Other Name: polyethylene glycol 3350 and electrolytes oral solution

Active Comparator: Group C
Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.
Drug: Clenpiq
bowel preparation
Other Name: sodium picosulfate, magnesium oxide, anhydrous citric acid

Active Comparator: Group D
Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Drug: Clenpiq
bowel preparation
Other Name: sodium picosulfate, magnesium oxide, anhydrous citric acid




Primary Outcome Measures :
  1. Percentage of participants with satisfactory bowel cleansing [ Time Frame: 1 day ]
    Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis.


Secondary Outcome Measures :
  1. Tolerability of the bowel preparation [ Time Frame: 1 day ]
    Participants will complete a written questionnaire which includes a modified 5-point Likert scale for ease of use (score 5-1: very easy, easy, tolerable, difficult or very difficult) and for palatability ( score 5-1: very good, good, fair, bad or worst)

  2. Percentage of participants requiring a repeat colonoscopy [ Time Frame: 1 day ]
    Participants requiring a repeat procedure due to unsatisfactory bowel prep



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198221


Contacts
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Contact: Hennie Hasson, RN 216-444-6975 hassonh@ccf.org
Contact: Carol Burke, MD 216-444-6864 burkec1@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hennie Hasson, RN    216-444-6975    hassonh@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Carol Burke, MD The Cleveland Clinic

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Responsible Party: Carol Burke, MD, Staff, Department of Gastroenterology/Hepatology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03198221     History of Changes
Other Study ID Numbers: 17-127
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carol Burke, MD, The Cleveland Clinic:
Golytely, Clenpiq, bowel prep
Additional relevant MeSH terms:
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Picosulfate sodium
Magnesium Oxide
Polyethylene glycol 3350
Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Antacids
Laxatives