Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-02 @ 1:04 AM
Study NCT ID:
NCT04708366
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 846}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with adequate colon cleansing', 'timeFrame': 'During the procedure.', 'description': 'Efficacy will be assessed as the percentage of patients with adequate bowel cleansing, as rated according to the Boston Bowel Preparation Scale (BBPS). This scale gives 0-3 points to each of the three colonic segments (i.e. right colon, transverse colon, and left colon); 0 points are assigned for the worst segment cleansing, whereas at least 2 points stand for adequate segment cleansing. Adequate colon cleansing is defined when at least 2 points are reached in each colonic segment.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'hospitalized patients', 'bowel preparation'], 'conditions': ['Colon Disease']}, 'descriptionModule': {'briefSummary': 'An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.\n\nAim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.', 'detailedDescription': "An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Such a low efficacy has several negative consequences: first, it leads to repetition of colonoscopy, therefore prolonging patients' in-hospital stay and increasing the risk of adverse events and costs; second, it augments the risk of missing colorectal lesions, negatively affecting patients' management and increasing costs due to the need for adjunctive diagnostic studies.\n\nCurrent recommendations on bowel preparation among difficult-to-prepare patients are mostly based on expert opinions, the high-volume 4L polyethylene glycol (PEG)-based prep being considered as the gold standard, possibly with further additional solution. On the other hand, compliance to the bowel preparation has been related to an adequate colon cleansing, and it may be argued that inpatients might find it difficult to take high-volume purge. A recent Italian prospective multicentre study among inpatients showed similar rates of adequate bowel preparation between patients who underwent bowel preparation with and without additional solution. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.\n\nAim of the present randomized multicenter controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients scheduled for elective colonoscopy\n* bowel preparation performed inside the hospital\n* ≥18 years old\n\nExclusion Criteria:\n\n* known or suspected ileus\n* gastrointestinal obstruction\n* gastric retention\n* bowel perforation\n* toxic colitis, or megacolon\n* phenylketonuria\n* glucose-6-phosphate dehydrogenase deficiency\n* active intestinal bleeding\n* emergency colonoscopy\n* dementia or illness requiring nasogastric tube for bowel prep administration\n* refusal to participate or inability to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT04708366', 'acronym': 'INTERPRET', 'briefTitle': 'Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Colon Cleansing Efficacy With 1L PEG Versus 2L PEG and 4L PEG for Colonoscopy Among Inpatients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'INTERPRET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1L PEG', 'description': 'Patients will be prepared with 1L-PEG-based bowel preparation.', 'interventionNames': ['Drug: NER1006']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2L PEG', 'description': 'Patients will be prepared with 2L-PEG-based bowel preparation.', 'interventionNames': ['Drug: MoviPrep']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4L PEG', 'description': 'Patients will be prepared with 4L-PEG-based bowel preparation.', 'interventionNames': ['Drug: Macrogol 400']}], 'interventions': [{'name': 'NER1006', 'type': 'DRUG', 'otherNames': ['IMP-1'], 'description': 'Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.', 'armGroupLabels': ['1L PEG']}, {'name': 'MoviPrep', 'type': 'DRUG', 'otherNames': ['IMP-2'], 'description': 'Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.', 'armGroupLabels': ['2L PEG']}, {'name': 'Macrogol 400', 'type': 'DRUG', 'otherNames': ['IMP-3'], 'description': 'Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.', 'armGroupLabels': ['4L PEG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'country': 'Italy', 'facility': "Policlinico Sant'Orsola-Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Lorenzo Fuccio', 'role': 'CONTACT', 'email': 'lorenzofuccio@gmail.com', 'phone': '+39 051 2143338'}], 'overallOfficials': [{'name': 'Lorenzo Fuccio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gastroenterology', 'investigatorFullName': 'Lorenzo Fuccio', 'investigatorAffiliation': 'University of Bologna'}}}}