Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep
1 other identifier
interventional
16
1 country
1
Brief Summary
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 6, 2019
June 1, 2019
7 months
January 29, 2019
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Blood pressure
Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Saturation
Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Heart rate
Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Respiration frequency
Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination
Study Arms (2)
Geloprep
EXPERIMENTALNovel and patented Polyethylene glycol 3350 mixture
Moviprep
ACTIVE COMPARATORStandard of care Polyethylene glycol 3350 mixture
Interventions
Eligibility Criteria
You may qualify if:
- \- Healthy
You may not qualify if:
- Allergy to content of products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zealand University Hospitallead
- University of Copenhagencollaborator
Study Sites (1)
Zuh
Køge, Region of Zealand, 4600, Denmark
Study Officials
- STUDY CHAIR
Ismail Gögenur, Professor MD
Department of Surgery, Zealand University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
April 5, 2019
Study Start
June 1, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
June 6, 2019
Record last verified: 2019-06