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

Phase 1

• Conditions: Pharmacological Action
• Interventions: Drug: A 06 ad

• Registration Number: NCT03904303
• Lead Sponsor: Zealand University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-05
• Status Verified: 2019-06
• Study Start: 2019-06-01
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy

Exclusion Criteria

• Allergy to content of products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Geloprep	A 06 ad	Novel and patented Polyethylene glycol 3350 mixture
Moviprep	A 06 ad	Standard of care Polyethylene glycol 3350 mixture

Primary Outcome Measures

Name	Time	Method
Boston Bowel preparation scale (BBPscale)	Performed during the endoscopy procedure	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.
Adverse events related to intervention	Assessed 4 hours after last intake of cleansing product	Any adverse event related to the intervention observed by investigators or as reported by the participant

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zuh; 🇩🇰 Køge, Region Of Zealand, Denmark