Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 9:24 PM
Study NCT ID:
NCT07465705
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008353', 'term': 'Mannitol'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 1:1, parallel-group, endoscopist-blinded'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 412}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Efficacy', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Number, appearance, size, location, and histological examination of neoplastic and inflammatory colorectal lesions.'}, {'measure': 'Adherence', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy', 'description': 'Adherence: study drug completely taken, partially taken, not taken.'}, {'measure': 'Ease of use', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy', 'description': 'Ease of use: numeric rating scale (NRS) (0 = very difficult to 10 = very easy).'}, {'measure': 'Taste', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy', 'description': 'Taste: NRS (0 = terrible to 10 = very good).'}, {'measure': 'Willingness to reuse the preparation', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy', 'description': 'Willingness to reuse the preparation (yes/no).'}, {'measure': 'Satisfaction with bowel preparation compared to cleansing agent used for previous colonoscopy.', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy', 'description': 'Satisfaction with bowel preparation compared to cleansing agent used for previous colonoscopy.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'From signature of the informed consent form up to and including V5, maximum 29 days after signing the informed consent form', 'description': 'Incidence of adverse events starting from the beginning of study drug administration.'}, {'measure': 'Incidence of drug-related adverse events', 'timeFrame': 'From signature of the informed consent form up to and including V5, maximum 29 days after signing the informed consent form', 'description': 'Incidence of drug-related adverse events starting from the beginning of study drug self-administration'}, {'measure': 'Proportion of subjects with clinically significant change from baseline of haematological and chemical parameters', 'timeFrame': 'At visit 2 (maximum 21 days after signing the informed consent form) and V4 (maximum 28 days after signing the informed consent form)', 'description': "Proportion of subjects with clinically significant change from baseline of haematological and chemical parameters 4 hours and 8 hours after completion of study drug self-administration, where clinically significant means that in the Investigator's opinion the change needs an additional control or a medical intervention."}, {'measure': 'Proportion of subjects with clinically significant change from baseline of heart rate, systolic and diastolic blood', 'timeFrame': 'At visit 2 (maximum 21 days after signing the informed consent form) and V4 (maximum 28 days after signing the informed consent form)', 'description': "Proportion of subjects with clinically significant change from baseline of heart rate, systolic and diastolic blood pressure measured from the beginning of study drug self-administration to the end of study, as well as clinically significant change of oxygen saturation during colonoscopy, where clinically significant means that in the Investigator's opinion the change needs an additional control or a medical intervention."}, {'measure': 'PK sub-study: Cmax', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form', 'description': 'Maximum Peak Plasma Concentration observed concentration (Cmax).'}, {'measure': 'PK sub-study: tmax', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form', 'description': 'Time to maximum observed concentration (tmax).'}, {'measure': 'PK sub-study: AUC0-t or AUClast', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form', 'description': 'Area under concentration-time curve, from 0 to the last blood sampling time point with measurable concentration (i.e., the last quantifiable timepoint) (AUC0-t or AUClast).'}, {'measure': 'PK sub-study: t1/2', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form', 'description': 'Elimination half-life (t1/2).'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Adenoma detection rate, defined as the proportion of subjects ≥ 50 years old undergoing colonoscopy who have at least one lesion detected.'}, {'measure': 'Caecal intubation rate', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Caecal intubation rate, defined as the proportion of subjects undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist.'}, {'measure': 'Proportion of subjects undergoing colonoscopy who have to repeat the procedure', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Proportion of subjects undergoing colonoscopy who have to repeat the procedure due to inadequate intestinal cleansing to resolve, at the discretion of the endoscopist, the clinical issue underlying the request for colonoscopy.'}, {'measure': 'Proportion of subjects undergoing colonoscopy with presence of colonic bubbles', 'timeFrame': 'During colonoscopy (visit4), maximum 28 days after signing the informed consent form)', 'description': 'Proportion of subjects undergoing colonoscopy with presence of colonic bubbles assessed through the Colon Endoscopic Bubble Scale (CEBuS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy preparation', 'Bowel cleansing', 'Mannitol'], 'conditions': ['Elective Colonoscopy']}, 'descriptionModule': {'briefSummary': 'This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.', 'detailedDescription': 'Not provided'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability of subject to consent and provide signed written informed consent.\n2. Age ≥ 18 years.\n3. Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.\n4. Subjects willing and able to complete the entire study and to comply with instructions.\n\nExclusion Criteria:\n\n1. Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2\\* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).\n2. Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn\'s Disease Activity Index - CDAI \\< 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.\n3. Severe renal failure: eGFR \\< 30 ml/min/1.73 m2 estimated by simplified MDRD equation.\n4. Severe heart failure: New York Heart Association (NYHA) Class III-IV.\n5. Severe anaemia (Hb ≤ 8 g/dl).\n6. Chronic liver disease Child-Pugh class B or C.\n7. Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).\n8. Clinically significant alterations of baseline haemato-chemical parameters.\n9. Recent (\\< 6 months) symptomatic acute ischemic heart disease.\n10. History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann\'s procedure and other surgeries involving the structure and function of the colon.\n11. History of paralysis of the gut (ileus).\n12. History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).\n13. History of phenylketonuria (due to presence of aspartame).\n14. History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).\n15. History of toxic megacolon.\n16. Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.\n17. Suspected bowel obstruction or perforation.\n18. Indication for partial colonoscopy.\n19. Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.\n20. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.\n21. Underwater colonoscopy instead of standard gas insufflation.'}, 'identificationModule': {'nctId': 'NCT07465705', 'acronym': 'CLEARWAY', 'briefTitle': 'Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NTC srl'}, 'officialTitle': 'A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY', 'orgStudyIdInfo': {'id': 'Mannitol_01-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test arm', 'description': 'One day single dose preparation same day of colonoscopy', 'interventionNames': ['Drug: 100g of Mannitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1L PEG-Asc', 'description': 'Two liters of overall preparation, taken according to split-dose regimen the same day of colonoscopy', 'interventionNames': ['Drug: 1L PEG-Asc']}], 'interventions': [{'name': '100g of Mannitol', 'type': 'DRUG', 'description': 'Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water', 'armGroupLabels': ['Test arm']}, {'name': '1L PEG-Asc', 'type': 'DRUG', 'description': 'Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.', 'armGroupLabels': ['1L PEG-Asc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Anderlecht', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Arnaud Lemmers, Prof.', 'role': 'CONTACT'}], 'facility': 'Hopital Erasme', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Raf Bisschops, Prof.', 'role': 'CONTACT'}], 'facility': 'Katholieke Universiteit te Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8400', 'city': 'Ostend', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pieter DeWint, Prof.', 'role': 'CONTACT'}], 'facility': 'Algemeen Ziekenhuis Damiaan Oostende', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}, {'zip': '41012', 'city': 'Carpi', 'state': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mauro Manno, Dr.', 'role': 'CONTACT'}], 'facility': 'Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Renato Cannizzaro, Prof.', 'role': 'CONTACT'}], 'facility': 'Centro Di Riferimento Oncologico Di Aviano', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Bocus, Dr.', 'role': 'CONTACT'}], 'facility': 'IRCCS Ospedale Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Fuccio, Dr.', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25124', 'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Cesaro, Dr.', 'role': 'CONTACT'}], 'facility': 'Fondazione Poliambulanza', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '22100', 'city': 'Como', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Franco Radaelli, Dr.', 'role': 'CONTACT'}], 'facility': "Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gian Eugenio Tontini, Prof.', 'role': 'CONTACT'}], 'facility': 'Fondazione IRCCS Cà Granda Ospedale Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe De Roberto, Dr.', 'role': 'CONTACT'}], 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristiano Spada, Prof.', 'role': 'CONTACT'}], 'facility': 'Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '38122', 'city': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Gabbrielli, Dr.', 'role': 'CONTACT'}], 'facility': 'Azienda Provinciale Per I Servizi Sanitari', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'zip': '43-100', 'city': 'Tychy', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marcin Romanczyk, Dr.', 'role': 'CONTACT'}], 'facility': 'H-T.Centrum Medyczne Sp. z o.o. sp.k.', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'zip': '02-665', 'city': 'Warsaw', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Poland', 'facility': 'Klinika Reuma Park Sp. z o.o. S.K.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-781', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Michal Filip Kaminski, Prof.', 'role': 'CONTACT'}], 'facility': 'Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Pellise Urquiza, Dr.', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic De Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '701 85', 'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Nills Nyhlin, Prof.', 'role': 'CONTACT'}], 'facility': 'Region Oerebro Laen', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'centralContacts': [{'name': 'Alessandro Colombo', 'role': 'CONTACT', 'email': 'alessandro.colombo@ntcpharma.com', 'phone': '+393512044335'}], 'overallOfficials': [{'name': 'Cristiano Spada, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Policlinico Universitario A. Gemelli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NTC srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}