Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-30 @ 6:29 AM
Study NCT ID:
NCT01842932
Status:
UNKNOWN
Last Update Posted:
2014-06-27
First Post:
2013-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness Of Flospan As A Premedication For Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010696', 'term': 'Phloroglucinol'}, {'id': 'C016859', 'term': 'cimetropium'}, {'id': 'D018680', 'term': 'Cholinergic Antagonists'}, {'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018678', 'term': 'Cholinergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2013-04-14', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bowel cleansing status', 'timeFrame': '1 year'}, {'measure': 'Heart rate, respiratory rate, oxygen saturation, blood pressure', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Non inferiority of phloroglucin to cimetropium bromide', 'timeFrame': 'Up to ten months', 'description': 'Comparing the two groups of time of examination, frequency of peristalsis, Scoring for the experimenter and the subject of the inspection feedback, double-blind setting.'}], 'secondaryOutcomes': [{'measure': 'Total diagnostic colonoscopy exam time', 'timeFrame': '1 year'}, {'measure': 'Evaluation of practitioners', 'timeFrame': '1 year', 'description': 'Colonic motility and test difficulty'}, {'measure': 'Evaluation of subjects', 'timeFrame': '1 year', 'description': 'The degree of discomfort after test'}, {'measure': 'Peristalsis time of transverse colon', 'timeFrame': '1 year', 'description': 'Total peristalsis time of transverse colon for two minutes'}, {'measure': 'Total dose and times of sedatives for pain control', 'timeFrame': '1 year', 'description': 'Total dose and times of sedatives (midazolam, propofol) for pain control'}, {'measure': 'Time of cecal intubation', 'timeFrame': '1 year', 'description': 'Total time of colonoscope intubation from anus to cecum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Anticholinergics'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial', 'detailedDescription': 'Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient endoscopic diagnostic purposes.\n\nExclusion Criteria:\n\n* If you currently pregnant, or of childbearing potential\n* Previous abdominal surgery or bowel resection.\n* If under 18 years of age\n* If the last two days, the administration of anticholinergic'}, 'identificationModule': {'nctId': 'NCT01842932', 'briefTitle': 'Usefulness Of Flospan As A Premedication For Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial', 'orgStudyIdInfo': {'id': 'AJIRB-MED-CT4-09-257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phloroglucin & Placebo', 'description': 'Phloroglucin 20ml before examination \\& Placebo 1ml before examination', 'interventionNames': ['Drug: Phloroglucin', 'Procedure: Colonoscopy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cimetropium bromide & Placebo', 'description': 'Cimetropium bromide 1ml before examination \\& Placebo 20ml before examination', 'interventionNames': ['Drug: Cimetropium bromide', 'Procedure: Colonoscopy', 'Drug: Placebo']}], 'interventions': [{'name': 'Phloroglucin', 'type': 'DRUG', 'otherNames': ['Flospan'], 'description': 'Premedication of colonoscopy', 'armGroupLabels': ['Phloroglucin & Placebo']}, {'name': 'Cimetropium bromide', 'type': 'DRUG', 'otherNames': ['Anticholinergics', 'Algiron'], 'description': 'Premedication of colonoscopy', 'armGroupLabels': ['Cimetropium bromide & Placebo']}, {'name': 'Colonoscopy', 'type': 'PROCEDURE', 'otherNames': ['Diagnostic examination of colon'], 'description': 'Diagnostic examination of colon', 'armGroupLabels': ['Cimetropium bromide & Placebo', 'Phloroglucin & Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.', 'armGroupLabels': ['Cimetropium bromide & Placebo', 'Phloroglucin & Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kee Myung Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lkm5104@ajou.ac.kr', 'phone': '82-31-219-6939'}, {'name': 'Sun Gyo Lim, M.D.', 'role': 'CONTACT', 'email': 'mdlsk75@hanmail.net', 'phone': '82-31-219-6939'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Kee Myung Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lkm5104@ajou.ac.kr', 'phone': '82-31-219-6939'}, {'name': 'Sun Gyo Lim, M.D.', 'role': 'CONTACT', 'email': 'mdlsk75@hanmail.net', 'phone': '82-31-219-6939'}], 'overallOfficials': [{'name': 'Kee Myung Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sun Gyo Lim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}