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Completed

NCT Number: NCT04150133

Effects and Tolerability With Clenpiq and Low Residue Diet

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

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Key information

Conditions

Colonoscopy Preparation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hillmont GI

Flourtown, Pennsylvania, 19031, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Residue Diet

Other

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

Primary outcomes

  1. Statistical equivalence of the clear liquid and low residue cohorts

    Time frame: 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 outcomes

  1. Polyp Detection Rate

    Time frame: Post Procedure Up to 24 hours

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

Sponsors and collaborators

Lead sponsor

Hillmont GI

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2019
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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