Effects and Tolerability With Clenpiq and Low Residue Diet

Hillmont GI

Status: Completed

Conditions: Colonoscopy Preparation

Treatments: Other: Low Residue Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04150133

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Details and patient eligibility

About

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

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Traditional Clear Liquid Arm

Active Comparator group

Description:

Following instructions with FDA-labeled clear liquids

Treatment:

Other: Low Residue Diet

Low Residue Diet Arm

Experimental group

Description:

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

Treatment:

Other: Low Residue Diet