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

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

Detailed Description
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Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy. Study performed in health subjects.

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

Conditions
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Pharmacological Action

Intervention / Treatment
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* Drug: A 06 ad


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy Exclusion Criteria: Allergy to content of products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |