Pharmacological Action Clinical Trial
Official title:
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
Status | Not yet recruiting |
Enrollment | 16 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Healthy Exclusion Criteria: - Allergy to content of products |
Country | Name | City | State |
---|---|---|---|
Denmark | Zuh | Køge | Region Of Zealand |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Heart rate | Heart rate | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination | |
Secondary | Respiration frequency | Respiration frequency | Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination |
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