Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT02274961
Status:
UNKNOWN
Last Update Posted:
2014-10-27
First Post:
2014-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-pantoprazole 10mg Phase III Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096663', 'term': 'Non-Erosive Reflux Disease'}], 'ancestors': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Erosive Reflux Disease']}, 'descriptionModule': {'briefSummary': 'This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults between the ages of 19 and 75 inclusive\n* Patient with a history of heartburn or acid regurgitation for at least 3 months.\n* Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline\n* Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening\n* Capable of providing written informed consent, willing and able to a comply with all procedures of the study\n\nExclusion Criteria:\n\n* History of endoscopic erosive esophagitis(EE) at screening EGD.\n* Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome\n* More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus\n* Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit\n* H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening\n* Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,\n* Known hypersensitivity to any component of drug\n* pregnancy or lactation (F only)"}, 'identificationModule': {'nctId': 'NCT02274961', 'briefTitle': 'S-pantoprazole 10mg Phase III Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ahn-Gook Pharmaceuticals Co.,Ltd'}, 'orgStudyIdInfo': {'id': 'LTP10_KR_1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-pantoprazole 10mg', 'description': 'S-pantoprazole 10mg Tablet once daily for 4 weeks', 'interventionNames': ['Drug: S-pantoprazole 10mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet for the test drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'S-pantoprazole 10mg', 'type': 'DRUG', 'armGroupLabels': ['S-pantoprazole 10mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'state': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Si-Hyung Lee, Professor', 'role': 'CONTACT'}], 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Su-Jin Hong, Professor', 'role': 'CONTACT'}], 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Sung-Nam', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Gwang-Hyun Go, Professor', 'role': 'CONTACT'}], 'facility': 'Bundang CHA Medical Center'}, {'city': 'Sung-Nam', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Ho Lee, Professor', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital'}, {'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hun-Yong Jung, Professor', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Jin Park, Professor', 'role': 'CONTACT'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji-Won Kim, Professor', 'role': 'CONTACT'}], 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Gyun Kim, Professor', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong-Chan Lee, Professor', 'role': 'CONTACT'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JINHYUNG KIM', 'role': 'CONTACT', 'email': 'jhkim04@ahn-gook.com', 'phone': '82-2-3289-4362'}], 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JINHYUNG KIM, Senior Researcher', 'role': 'CONTACT', 'email': 'jhkim04@ahn-gook.com', 'phone': '82-2-3289-4362'}, {'name': 'Chulhun Sung, Senior Researcher', 'role': 'CONTACT', 'email': 'sch9013@ahn-gook.com', 'phone': '82-2-3289-4284'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahn-Gook Pharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}