Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-27 @ 2:15 PM
Study NCT ID:
NCT03904303
Status:
UNKNOWN
Last Update Posted:
2019-06-06
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Bowel preparation scale (BBPscale)', 'timeFrame': 'Performed during the endoscopy procedure', 'description': '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.'}, {'measure': 'Adverse events related to intervention', 'timeFrame': 'Assessed 4 hours after last intake of cleansing product', 'description': 'Any adverse event related to the intervention observed by investigators or as reported by the participant'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination', 'description': 'mmHg systolic and diastolic measured on right or left arm.'}, {'measure': 'Saturation', 'timeFrame': 'Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination', 'description': 'Oxymeter measuring the saturation of hemoglobin with oxygen as a percentage of 0-100%.'}, {'measure': 'Heart rate', 'timeFrame': 'Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination', 'description': 'Heart rate'}, {'measure': 'Respiration frequency', 'timeFrame': 'Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination', 'description': 'Respiration frequency'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacological Action']}, 'descriptionModule': {'briefSummary': 'Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy', 'detailedDescription': 'Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.\n\nStudy performed in health subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy\n\nExclusion Criteria:\n\n* Allergy to content of products'}, 'identificationModule': {'nctId': 'NCT03904303', 'briefTitle': 'Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study', 'orgStudyIdInfo': {'id': 'REG-014-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Geloprep', 'description': 'Novel and patented Polyethylene glycol 3350 mixture', 'interventionNames': ['Drug: A 06 ad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moviprep', 'description': 'Standard of care Polyethylene glycol 3350 mixture', 'interventionNames': ['Drug: A 06 ad']}], 'interventions': [{'name': 'A 06 ad', 'type': 'DRUG', 'description': 'Colonic cleansing before colonoscopy and CT colonografi', 'armGroupLabels': ['Geloprep', 'Moviprep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'state': 'Region of Zealand', 'country': 'Denmark', 'facility': 'Zuh', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'centralContacts': [{'name': 'Hanne Holm, RN', 'role': 'CONTACT', 'email': 'hanh@regionsjaelland.dk', 'phone': '+4593567014'}, {'name': 'Svend Knuhtsen, MD', 'role': 'CONTACT', 'email': 'svkn@regionsjaelland.dk', 'phone': '+4523348555'}], 'overallOfficials': [{'name': 'Ismail Gögenur, Professor MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, Zealand University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}