Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-04 @ 6:55 AM
Study NCT ID:
NCT02781493
Status:
UNKNOWN
Last Update Posted:
2016-05-27
First Post:
2016-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2016-05-21', 'studyFirstSubmitQcDate': '2016-05-21', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.', 'timeFrame': '9 months', 'description': 'This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups.'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate between 2 groups.', 'timeFrame': '9 months'}, {'measure': 'rate of adverse events between 2 groups.', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prucalopride', 'Polyethylene Glycol', 'bowel preparation'], 'conditions': ['Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp']}, 'descriptionModule': {'briefSummary': 'Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.', 'detailedDescription': 'Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.\n\nPrucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older,\n* scheduled to undergo elective outpatient colonoscopy,\n* and were able to provide informed consent.\n\nExclusion Criteria:\n\n* history of colorectal surgery\n* severe colonic stricture or obstructing tumour\n* dysphagia\n* compromised swallowing reflex or mental status\n* significant gastroparesis or gastric outlet obstruction\n* known or suspected bowel obstruction or perforation\n* severe chronic renal failure (creatinine clearance\\<30 ml/min\n* severe congestive heart failure (New York Heart Association class III or IV)\n* uncontrolled hypertension (systolic blood pressure\\>170 mm Hg, diastolic blood pressure\\>100 mm Hg)\n* dehydration\n* disturbance of electrolytes\n* pregnancy or lactation\n* haemodynamically unstable\n* unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT02781493', 'briefTitle': 'Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'orgStudyIdInfo': {'id': '2016SDU-QILU-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prucalopride group', 'description': '2 mg Prucalopride plus 2 L Polyethylene Glycol regimen', 'interventionNames': ['Drug: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '2 mg Placebo plus 2 L Polyethylene Glycol regimen', 'interventionNames': ['Drug: 2 mg Placebo plus 2 L Polyethylene Glycol regimen']}], 'interventions': [{'name': '2 mg Prucalopride plus 2 L Polyethylene Glycol regimen', 'type': 'DRUG', 'description': 'Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.', 'armGroupLabels': ['Prucalopride group']}, {'name': '2 mg Placebo plus 2 L Polyethylene Glycol regimen', 'type': 'DRUG', 'description': 'Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, MD, PhD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-0531-82169236'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Li Yanqing, MD, PhD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236'}], 'overallOfficials': [{'name': 'Li Yanqing, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': "Binzhou People's Hospital", 'class': 'OTHER'}, {'name': "Tai'an People's Hospital", 'class': 'UNKNOWN'}, {'name': "Linyi People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}