Effects and Tolerability With Clenpiq and Low Residue Diet

• Sponsor: Hillmont GI (Other)
• Overall Status: Completed
• CT.gov ID: NCT04150133
• Collaborator: Ferring Pharmaceuticals (Industry)
• Enrollment: 154
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.3
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy Preparation	Other: Low Residue Diet	N/A

Detailed Description

This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue dietsingle blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
• Masking: Single (Investigator)
• Masking Description: Investigator will be ignorant of how preparation was taken
• Primary Purpose: Other
• Official Title: The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative
• Actual Study Start Date: Nov 21, 2019
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional Clear Liquid Arm Following instructions with FDA-labeled clear liquids	Other: Low Residue Diet; Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy
Experimental: Low Residue Diet Arm Following instructions for a low residue diet along with FDA-labeled clear liquids	Other: Low Residue Diet; Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy

Outcome Measures

Primary Outcome Measures

1. Statistical equivalence of the clear liquid and low residue cohorts [During Colonoscopy Up to 24 hours]

   Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy

Secondary Outcome Measures

1. Polyp Detection Rate [Post Procedure Up to 24 hours]

   Number of polyps detected and removed per total number of patients in each arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All subjects age 18-80 requiring colonoscopy for appropriate indications

Exclusion Criteria:

• Active diarrhea (Greater than 3 unformed stools daily)

• Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.

Additional exclusion criteria would include;

• Subjects with a history of inflammatory bowel disease

• Colonic resection of any length

• Pregnant women

• American Society of Anesthesiologists (ASA) score greater than 3

• Body Mass Index (BMI) greater than 50

• Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines.

• Subjects unable to give their own informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillmont GI	Flourtown	Pennsylvania	United States	19031

Sponsors and Collaborators

• Hillmont GI
• Ferring Pharmaceuticals

Investigators

• Principal Investigator: Gerald Bertiger, MD, Hillmont GI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hillmont GI
• ClinicalTrials.gov Identifier: NCT04150133
• Other Study ID Numbers: foodprep2019
• First Posted: Nov 4, 2019
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hillmont GI: low residue diet

Study Results

No Results Posted as of Mar 16, 2022