Effects and Tolerability With Clenpiq and Low Residue Diet

NCT04150133 | Completed

• 1 other identifier: foodprep2019
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy Preparation

Keywords

low residue diet

Outcome Measures

Primary Outcomes (1)

• Statistical equivalence of the clear liquid and low residue cohorts

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

  During Colonoscopy Up to 24 hours

Secondary Outcomes (1)

• Polyp Detection Rate

  Post Procedure Up to 24 hours

Study Arms (2)

Traditional Clear Liquid Arm

ACTIVE COMPARATOR

Following instructions with FDA-labeled clear liquids

Other: Low Residue Diet

Low Residue Diet Arm

EXPERIMENTAL

Following instructions for a low residue diet along with FDA-labeled clear liquids

Other: Low Residue Diet

Interventions

Low Residue Diet OTHER

Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy

Low Residue Diet Arm; Traditional Clear Liquid Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hillmont GI: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Hillmont GI

Flourtown, Pennsylvania, 19031, United States

Location

Study Officials

• Gerald Bertiger, MD

  Hillmont GI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be ignorant of how preparation was taken
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 4, 2019
• Study Start: November 21, 2019
• Primary Completion: January 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)