Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
Study NCT ID:
NCT03943992
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2019-03-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LA grade 0(zero)', 'timeFrame': 'within 8 weeks', 'description': "Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8.\n\nCalculation of the sample size was based on a margin of non-inferiority by Normal approximation."}], 'secondaryOutcomes': [{'measure': 'LA grade 0(zero)', 'timeFrame': 'at 4 weeks', 'description': "Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test."}, {'measure': 'Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).', 'timeFrame': 'at week 4 and 8 from baseline', 'description': "Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test."}, {'measure': 'Frequency variation of the Heartburn in daytime by patients diary', 'timeFrame': 'at 4 week and 8 week from baseline', 'description': "Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test."}, {'measure': 'Frequency variation of the Heartburn in nighttime by patients diary', 'timeFrame': 'at 4 week and 8 week from baseline', 'description': "Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test."}, {'measure': 'Days percentage(%) of no symptoms about the Heartburn and acid regurgitation', 'timeFrame': 'at week 4 and 8 from baseline', 'description': 'Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).', 'detailedDescription': "This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A man or woman over 20 years old less than 70 years old.\n* A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A\\~D) measured through the endoscopy which is carried out within (-2W±D2)\n\n \\* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.\n 1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.\n 2. Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.\n* A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.\n\nExclusion Criteria:\n\n* Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.\n* Who has NERD\n* Who get a diagnosis as a IBS within the last 3 months.\n* Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.\n* Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (\\* refer to the Concomitant medication in text.)\n* Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.\n* Who has clinically significant abnormal result of ECG.\n* Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.\n* Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus."}, 'identificationModule': {'nctId': 'NCT03943992', 'briefTitle': 'Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yooyoung Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).', 'orgStudyIdInfo': {'id': 'YYPCT_YYD601_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YYD601 40mg', 'description': 'Esomeprazole magnesium Dihydrate.', 'interventionNames': ['Drug: YYD601 40mg', 'Drug: Placebos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nexium 40mg', 'description': 'Esomeprazole magnesium trihydrate, a substituted benzimidazole.', 'interventionNames': ['Drug: Nexium 40mg', 'Drug: Placebos']}], 'interventions': [{'name': 'YYD601 40mg', 'type': 'DRUG', 'description': 'Patients should take druges 30 minutes before breakfast.', 'armGroupLabels': ['YYD601 40mg']}, {'name': 'Nexium 40mg', 'type': 'DRUG', 'description': 'Patients should take druges 30 minutes before breakfast.', 'armGroupLabels': ['Nexium 40mg']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.', 'armGroupLabels': ['Nexium 40mg', 'YYD601 40mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yooyoung Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}