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

Sponsor
Zealand University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03904303
Collaborator
University of Copenhagen (Other)
16
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: A 06 ad
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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%.

  3. Heart rate [Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination]

    Heart rate

  4. Respiration frequency [Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination]

    Respiration frequency

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy
Exclusion Criteria:
  • Allergy to content of products

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zuh Køge Region Of Zealand Denmark 4600

Sponsors and Collaborators

  • Zealand University Hospital
  • University of Copenhagen

Investigators

  • Study Chair: Ismail Gögenur, Professor MD, Department of Surgery, Zealand University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zealand University Hospital
ClinicalTrials.gov Identifier:
NCT03904303
Other Study ID Numbers:
  • REG-014-2018
First Posted:
Apr 5, 2019
Last Update Posted:
Jun 6, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 6, 2019