Comparison of Clenpiq vs Golytely Bowel Preparation

NCT03198221 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17-127
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation Solutions

Keywords

Golytely, Clenpiq, bowel prep

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Satisfactory Bowel Cleansing

  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.

  1 day

Secondary Outcomes (1)

• Proportion of Participants Requiring a Repeat Colonoscopy

  1 day

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Group D

ACTIVE COMPARATOR

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

Interventions

Golytely DRUG

bowel preparation

Also known as: polyethylene glycol 3350 and electrolytes oral solution

Group A; Group B

Clenpiq DRUG

bowel preparation

Also known as: sodium picosulfate, magnesium oxide, anhydrous citric acid

Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Golytely; polyethylene glycol 3350; Electrolytes; picosulfate sodium; Magnesium Oxide; Citric Acid

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Magnesium Compounds; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Carol Burke
• Organization: Cleveland Clinic

BurkeC1@ccf.org

216-444-6864

Study Officials

• Carol Burke, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Department of Gastroenterology/Hepatology

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: July 11, 2018
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)