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Trial record 9 of 190 for:    Recruiting, Not yet recruiting, Available Studies | Pharmacology

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

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ClinicalTrials.gov Identifier: NCT03904303
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Zealand University Hospital

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
Pharmacological Action 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: MoviPrep

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




Primary Outcome Measures :
  1. Boston Bowel preparation scale (BBPscale) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination ]
    Respiration frequency



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Healthy

Exclusion Criteria:

  • Allergy to content of products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904303


Contacts
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Contact: Hanne Holm, RN +4593567014 hanh@regionsjaelland.dk
Contact: Svend Knuhtsen, MD +4523348555 svkn@regionsjaelland.dk

Locations
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Denmark
Zuh
Køge, Region Of Zealand, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
University of Copenhagen
Investigators
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Study Chair: Ismail Gögenur, Professor MD Department of Surgery, Zealand University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03904303     History of Changes
Other Study ID Numbers: REG-014-2018
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents