Effects and Tolerability With Clenpiq and Low Residue Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2021-10-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colonoscopy Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Investigator will be ignorant of how preparation was taken

Study Groups

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Traditional Clear Liquid Arm

Following instructions with FDA-labeled clear liquids

Group Type ACTIVE_COMPARATOR

Low Residue Diet

Intervention Type OTHER

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

Low Residue Diet Arm

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

Group Type EXPERIMENTAL

Low Residue Diet

Intervention Type OTHER

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

Interventions

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Low Residue Diet

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

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes