Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep

Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study

Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy

Study Overview

• Status: Unknown
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: A 06 ad

Detailed Description

Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.

Study performed in health subjects.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hanne Holm, RN; Phone Number: +4593567014; Email: hanh@regionsjaelland.dk
• Study Contact Backup: Name: Svend Knuhtsen, MD; Phone Number: +4523348555; Email: svkn@regionsjaelland.dk

Study Locations

• Denmark
  • Region Of Zealand
    • Køge, Region Of Zealand, Denmark, 4600
      • Zuh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Healthy

Exclusion Criteria:

• Allergy to content of products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Geloprep; Novel and patented Polyethylene glycol 3350 mixture	Drug: A 06 ad; Colonic cleansing before colonoscopy and CT colonografi
Active Comparator: Moviprep; Standard of care Polyethylene glycol 3350 mixture	Drug: A 06 ad; Colonic cleansing before colonoscopy and CT colonografi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel preparation scale (BBPscale)	Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9.	Performed during the endoscopy procedure
Adverse events related to intervention	Any adverse event related to the intervention observed by investigators or as reported by the participant	Assessed 4 hours after last intake of cleansing product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	mmHg systolic and diastolic measured on right or left arm.	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Saturation	Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%.	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Heart rate	Heart rate	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Respiration frequency	Respiration frequency	Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: University of Copenhagen
• Investigators: Study Chair: Ismail Gögenur, Professor MD, Department of Surgery, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: REG-014-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No