Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-04 @ 9:26 PM
Study NCT ID:
NCT02967094
Status:
UNKNOWN
Last Update Posted:
2016-11-29
First Post:
2016-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mucolytic Solution Before Upper Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024632', 'term': 'Espumisan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-27', 'studyFirstSubmitDate': '2016-11-10', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Visibility score" evaluated by blinded performing endoscopist', 'timeFrame': 'through study completion, an average of 3 months', 'description': '"Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).'}], 'secondaryOutcomes': [{'measure': '"Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.', 'timeFrame': 'through study completion, an average of 3 months', 'description': '"Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).'}, {'measure': 'Residual fluid in the stomach evaluated by blinded performing endoscopist', 'timeFrame': 'through study completion, an average of 3 months', 'description': '0-3 point scale'}, {'measure': 'Duration of endoscopy', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'time between introduction and withdrawal of the endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroscopy; Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '34158672', 'type': 'DERIVED', 'citation': 'Stepan M, Falt P, Pipek B, Fojtik P, Hanousek M, Hill M, Urban O. Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Mar;167(1):69-73. doi: 10.5507/bp.2021.038. Epub 2021 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.', 'detailedDescription': 'Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* signed informed consent\n* diagnostic gastroscopy\n\nExclusion Criteria:\n\n* age \\< 18 years\n* interventional gastroscopy\n* known disease of the upper GI tract and/or history of surgery of GI tract\n* gastroscopy indicated of bleeding, dysphagia or ileus\n* liver cirrhosis\n* general anesthesia'}, 'identificationModule': {'nctId': 'NCT02967094', 'briefTitle': 'Mucolytic Solution Before Upper Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Vitkovice Hospital'}, 'officialTitle': 'The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial', 'orgStudyIdInfo': {'id': 'DDC VN 09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - mucolytic solution', 'description': 'Mucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.', 'interventionNames': ['Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)']}, {'type': 'NO_INTERVENTION', 'label': 'B - no intervention', 'description': 'Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C - water', 'description': '100 ml of water given 30 minutes prior to upper endoscopy.', 'interventionNames': ['Drug: Administration of water before upper endoscopy']}], 'interventions': [{'name': 'Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)', 'type': 'DRUG', 'armGroupLabels': ['A - mucolytic solution']}, {'name': 'Administration of water before upper endoscopy', 'type': 'DRUG', 'armGroupLabels': ['C - water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70384', 'city': 'Ostrava', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Premysl Falt, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'faltprem@centrum.cz', 'phone': '+420602689561'}], 'facility': 'Digestive Diseases Center', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'centralContacts': [{'name': 'Premysl Falt, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'faltprem@centrum.cz', 'phone': '+420595633', 'phoneExt': '205'}, {'name': 'Barbora Pipek, M.D.', 'role': 'CONTACT', 'email': 'barbora.pipek@seznam.cz', 'phone': '+420595633', 'phoneExt': '205'}], 'overallOfficials': [{'name': 'Premysl Falt, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Digestive Diseases Center, Vítkovice Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitkovice Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Premysl Falt, M.D., Ph.D.', 'investigatorAffiliation': 'Vitkovice Hospital'}}}}