Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT02555228
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2015-09-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Small Volume Simethicone Before Gastroscopy: Any Benefit?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'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'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mingjun.song0950c@gmail.com', 'phone': '86337635', 'title': 'Dr Song Mingjun', 'organization': 'MOHH Holdings'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Any adverse event that occurs during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Cumulative Mucosal Visibility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.78', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': 'Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:\n\nScore of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured\n\nTotal areas covered:\n\n(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mucosal Visibility Score Per Area as Determined by Mc Nally Score:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}], 'classes': [{'title': 'Area E (esopahgus)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Area D (duodenum)', 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '2.26', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Area A (antrum and angularis)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Area B (body and fundus)', 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': '* Area E: esophagus\n* Area D: duodenum\n* Area A: antrum and angularis\n* Area B: body and fundus\n\nMc Nally score per area:\n\nScore of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Additional Manual Flushes Required During Endoscopy in Mls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.89', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '84.81', 'spread': '110.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': 'The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.', 'unitOfMeasure': 'mls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.\n\n27 patients randomized to this group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '20th August 2015', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': '14th August 2015', 'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '19th November 2015', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': '29th October 2015', 'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simethicone Premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water\n\nSimethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Just 5 mls of water\n\nWater: 5mls of water is given at least 30 minutes before the gastroscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '57.7', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male patients', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Female patients', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean premedication time (min:sec)', 'classes': [{'categories': [{'measurements': [{'value': '2686', 'spread': '756', 'groupId': 'BG000'}, {'value': '2468', 'spread': '596', 'groupId': 'BG001'}, {'value': '2577', 'spread': '676', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2015-09-13', 'resultsFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-15', 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cumulative Mucosal Visibility Score', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': 'Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:\n\nScore of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured\n\nTotal areas covered:\n\n(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus'}], 'secondaryOutcomes': [{'measure': 'Mucosal Visibility Score Per Area as Determined by Mc Nally Score:', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': '* Area E: esophagus\n* Area D: duodenum\n* Area A: antrum and angularis\n* Area B: body and fundus\n\nMc Nally score per area:\n\nScore of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured'}, {'measure': 'Volume of Additional Manual Flushes Required During Endoscopy in Mls', 'timeFrame': 'This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.', 'description': 'The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.'}, {'measure': 'Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution', 'timeFrame': 'Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['simethicone', 'gastroscopy', 'McNalley score'], 'conditions': ['Lesion of Stomach']}, 'descriptionModule': {'briefSummary': 'A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.', 'detailedDescription': 'Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope.\n\nSimethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 \\[1\\] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo.\n\nIn Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned for an elective diagnostic gastroscopy by the attending gastroenterologist\n* Age of at least 21 years old\n* Mentally competent and able to provide informed consent\n\nExclusion Criteria:\n\n* Category A patients (incarcerated prisoners)\n* adults who are unable to give their own informed consent due to lack of mental capacity\n* suspected gastrointestinal bleeding\n* suspected impacted foreign material\n* suspected gastric outlet obstruction\n* suspected esophageal obstruction\n* history of dysphagia\n* known hypersensitivity to simethicone\n* previous gastrectomy'}, 'identificationModule': {'nctId': 'NCT02555228', 'briefTitle': 'Small Volume Simethicone Before Gastroscopy: Any Benefit?', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study', 'orgStudyIdInfo': {'id': 'CGH-QIPSMJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simethicone premedication', 'description': 'Liquid simethicone (1ml volume) in 5mls of water', 'interventionNames': ['Drug: Simethicone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Just 5 mls of water', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'Simethicone', 'type': 'DRUG', 'description': '100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.', 'armGroupLabels': ['Simethicone premedication']}, {'name': 'Water', 'type': 'OTHER', 'description': '5mls of water is given at least 30 minutes before the gastroscopy.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data send to Singapore Health Sciences Authority'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}