Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-03-01 @ 6:03 AM
Study NCT ID:
NCT01689792
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': 'At colonoscopy', 'description': 'Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist'}], 'secondaryOutcomes': [{'measure': 'Adenoma Detection Rate (ADR)', 'timeFrame': 'At the Colonoscopy', 'description': 'ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population'}, {'measure': 'ADR and PDR by location', 'timeFrame': 'at the colonoscopy', 'description': 'ADR and PDR by location:\n\n* left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum\n* right-sided (right half of colon transversum, colon ascendens, caecum'}, {'measure': 'Cancer detection rate', 'timeFrame': 'at the colonoscopy', 'description': 'Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population'}, {'measure': 'Flat lesion only detection rate', 'timeFrame': 'at the colonoscopy', 'description': 'Flat lesion only detection of the patients'}, {'measure': 'Advanced risk lesion detection rate', 'timeFrame': 'at the colonoscopy', 'description': 'Advanced risk lesion detection rate (lesions \\>1 cm, low grade and/or villous'}, {'measure': 'Colonoscopy completion rate', 'timeFrame': 'at the colonoscopy', 'description': 'The rate of colonoscopy completion'}, {'measure': 'Colon cleansing quality', 'timeFrame': 'at the colonoscopy', 'description': 'Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©'}, {'measure': 'Acceptability and tolerability of medication using patient questionnaires', 'timeFrame': 'Throughout the study', 'description': 'The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25950434', 'type': 'DERIVED', 'citation': 'Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's written informed consent must be obtained prior to inclusion.\n* Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.\n* Willing to undergo a colonoscopy for diagnostic or surveillance purposes\n* Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy\n* Willing, able and competent to complete the entire procedure and to comply with study instructions.\n* Females of childbearing potential must employ an adequate method of contraception.\n\nExclusion Criteria:\n\n* History of gastric emptying disorders.\n* History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.\n* History of phenylketonuria.\n* Known glucose-6-phosphate dehydrogenase deficiency.\n* Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.\n* History of colonic resection.\n* Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).\n* Presence of congestive heart failure (NYHA III + IV).\n* Acute life-threatening cardiovascular disease.\n* Documented history of severe renal insufficiency (creatinine clearance \\<30 ml/min).\n* Other contraindication described in the summary of product characteristics (SmPC) of either preparation.\n* Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.\n* Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.\n* Females who are pregnant, nursing or planning a pregnancy.\n* Patients who, in the opinion of the investigator, may not be compliant with the study requirements.\n* Previous participation in this clinical study."}, 'identificationModule': {'nctId': 'NCT01689792', 'briefTitle': 'A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norgine'}, 'officialTitle': 'A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)', 'orgStudyIdInfo': {'id': 'NOR-01/2011 (PDR)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CitraFleet', 'description': 'Administration of CitraFleet', 'interventionNames': ['Drug: CitraFleet']}, {'type': 'EXPERIMENTAL', 'label': 'MOVIPREP', 'description': 'Administration of MOVIPREP', 'interventionNames': ['Drug: MOVIPREP']}], 'interventions': [{'name': 'MOVIPREP', 'type': 'DRUG', 'armGroupLabels': ['MOVIPREP']}, {'name': 'CitraFleet', 'type': 'DRUG', 'armGroupLabels': ['CitraFleet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Am Hasenkopf 1', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Klinikum Aschaffenburg', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}], 'overallOfficials': [{'name': 'Wolfgang Fishbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Aschaffenburg-Alzenau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norgine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}