Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 1:36 PM
Study NCT ID:
NCT04325620
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete resolution of major symptoms at 4-week', 'timeFrame': '4 week', 'description': 'Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with complete resolution of major symptoms at 2-week', 'timeFrame': '2 week', 'description': 'Complete resolution is defined as no episodes of symptom during the last 7 days of treatment'}, {'measure': 'Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)', 'timeFrame': '2, 4 week', 'description': 'RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.'}, {'measure': 'Time to complete resolution of major symptoms', 'timeFrame': '4 week', 'description': 'defined as time to the first day of complete resolution'}, {'measure': 'Resolution rate of major symptoms of first 7 days', 'timeFrame': '1 week', 'description': "defined as first of 7 days with no episodes of symptom using subject's diary"}, {'measure': 'Major symptoms-Free days', 'timeFrame': '1, 4 week', 'description': "Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary"}, {'measure': 'Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)', 'timeFrame': '4 week', 'description': 'PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.'}, {'measure': 'Proportion of rescue medication amounts', 'timeFrame': '4 week', 'description': 'Use of rescue medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-erosive Gastroesphageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.', 'detailedDescription': 'A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 19≤ age ≤ 75\n* Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy\n* Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day\n* Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ\n* Patients understood the consents and purpose of this trial and signed consent form\n\nExclusion Criteria:\n\n* Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy\n* Patients who have a history of gastric or gastroesophageal surgery\n* Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1\n* Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.\n* Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)\n* Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine \\>2.0mg/dL at Visit 1)"}, 'identificationModule': {'nctId': 'NCT04325620', 'briefTitle': 'Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)', 'orgStudyIdInfo': {'id': 'HM-ESOM-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIP1601 Amg', 'description': 'The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.', 'interventionNames': ['Drug: HIP1601']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HGP1805', 'description': 'The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.', 'interventionNames': ['Drug: HGP1805']}], 'interventions': [{'name': 'HIP1601', 'type': 'DRUG', 'description': 'HIP1601', 'armGroupLabels': ['HIP1601 Amg']}, {'name': 'HGP1805', 'type': 'DRUG', 'description': 'Placebo of HIP1601', 'armGroupLabels': ['HGP1805']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}