Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-06 @ 9:41 AM
Study NCT ID:
NCT06436833
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C581303', 'term': 'elobixibat'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison efficacy of bowel preparation before colonoscopy between 2 group', 'timeFrame': 'During colonoscopy procedure', 'description': 'Bowel preaparation measure by Boston bowel preparation scale'}], 'secondaryOutcomes': [{'measure': 'Overall procedural time of colonoscopy', 'timeFrame': 'During colonoscopy procedure', 'description': 'Duration since start colonoscopy insertion until withdrawal endoscope'}, {'measure': 'Cecal intubation rate', 'timeFrame': 'During colonoscopy procedure', 'description': 'Perform successful endoscopy to cecum'}, {'measure': 'Withdrawal time of colonoscopy', 'timeFrame': 'During colonoscopy procedure', 'description': 'Duration since endoscopy withdrawal from cecum to anal canal'}, {'measure': 'Adenoma detection rate', 'timeFrame': 'During colonoscopy procedure', 'description': 'At least one adenoma presented in this colonoscopy'}, {'measure': 'Patient satisfaction in their bowel preparation regimen', 'timeFrame': '1 day before colonoscopy', 'description': 'Satisfaction score evaluate by Linkert scale'}, {'measure': 'Adverse event in each group', 'timeFrame': 'During 24 hour after taking bowel preparation', 'description': 'Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bowel Preparation Solution', 'Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '33971037', 'type': 'BACKGROUND', 'citation': 'Yamaguchi D, Hidaka H, Matsunaga T, Akutagawa T, Tanaka Y, Jubashi A, Takeuchi Y, Tsuruoka N, Sakata Y, Miyahara K, Tominaga N, Kawakubo H, Takamori A, Shimoda R, Noda T, Ogata S, Tsunada S, Esaki M. Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study. Dig Endosc. 2022 Jan;34(1):171-179. doi: 10.1111/den.14010. Epub 2021 May 24.'}, {'pmid': '28840422', 'type': 'BACKGROUND', 'citation': 'Nakajima A, Seki M, Taniguchi S. Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial. J Gastroenterol. 2018 Apr;53(4):525-534. doi: 10.1007/s00535-017-1383-5. Epub 2017 Aug 24.'}, {'pmid': '27446836', 'type': 'BACKGROUND', 'citation': 'Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13.'}, {'pmid': '20883845', 'type': 'BACKGROUND', 'citation': 'Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.'}, {'pmid': '19136102', 'type': 'BACKGROUND', 'citation': 'Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.'}, {'pmid': '26232311', 'type': 'BACKGROUND', 'citation': 'Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6.'}, {'pmid': '25057297', 'type': 'BACKGROUND', 'citation': 'Acosta A, Camilleri M. Elobixibat and its potential role in chronic idiopathic constipation. Therap Adv Gastroenterol. 2014 Jul;7(4):167-75. doi: 10.1177/1756283X14528269.'}, {'pmid': '30793431', 'type': 'BACKGROUND', 'citation': 'Nakajima A, Taniguchi S, Kurosu S, Gillberg PG, Mattsson JP, Camilleri M. Efficacy, long-term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan. Neurogastroenterol Motil. 2019 May;31(5):e13571. doi: 10.1111/nmo.13571. Epub 2019 Feb 21.'}, {'pmid': '12135020', 'type': 'BACKGROUND', 'citation': 'Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen', 'detailedDescription': 'The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging\n\nRandomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram.\n\nGroup 2 the participant recieved Polyethylene 4 liter split dose\n\nResult of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adute aged 18-80 year old\n* Indication for colonoscopy(one selected)\n\n 1. Colorectal cancer screening\n 2. Stool occult blood test positive\n 3. History of colonic polyp\n 4. abdominal pain\n 5. Iron deficiency anemia\n 6. Chronic diarrhea\n 7. chronic constipation\n 8. Unintentional weight loss\n 9. Gastrointestinal bleeding\n 10. Abnormal imagind study\n* Participant acceptconsent information\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Gastroparesis, gastric outlet obstuction\n* Bowel obstruction\n* Gastrointestinal tract surgery\n* Inflammatory bowel disease\n* ASA(American society of anesthesiologist physical status) status \\> or = 4\n* Allergic to Elobixibat or PEG\n* Chronic kidney disease stage 4-5(GFR \\<30 ml/min)\n* Biliary tract obstruction\n* Previous history of inadequate bowel preparation'}, 'identificationModule': {'nctId': 'NCT06436833', 'briefTitle': 'Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '67017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2-Liter polyethylene glycol plus elobixibat', 'description': 'Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.', 'interventionNames': ['Drug: 2-Liter polyethylene glycol plus elobixibat']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4-Liter polyethylene glycol', 'description': 'Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.', 'interventionNames': ['Drug: 4-Liter polyethylene glycol']}], 'interventions': [{'name': '2-Liter polyethylene glycol plus elobixibat', 'type': 'DRUG', 'description': 'Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.', 'armGroupLabels': ['2-Liter polyethylene glycol plus elobixibat']}, {'name': '4-Liter polyethylene glycol', 'type': 'DRUG', 'description': 'Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.', 'armGroupLabels': ['4-Liter polyethylene glycol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rajavithi', 'role': 'CONTACT'}], 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Apichet Sirinawasatien, M.D.', 'role': 'CONTACT', 'email': 'sui_apichet@hotmail.com', 'phone': '023548108'}, {'name': 'Somchai Uthiwamek, M.D.', 'role': 'CONTACT', 'email': 'p3n_p1ng@hotmail.com', 'phone': '0851267424'}], 'overallOfficials': [{'name': 'Apichet Sirinawasatien, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan for IPD sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}