Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 10:36 AM
Study NCT ID:
NCT00761358
Status:
COMPLETED
Last Update Posted:
2010-11-23
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C410959', 'term': 'Z 338'}]}}, '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': 'ESTIMATED', 'count': 820}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-21', 'studyFirstSubmitDate': '2008-09-25', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General impression at last visit in treatment period', 'timeFrame': '4 week'}, {'measure': 'Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period', 'timeFrame': '4 week'}], 'secondaryOutcomes': [{'measure': 'Individual symptom score', 'timeFrame': 'Every week'}, {'measure': 'SF-NDI', 'timeFrame': 'At 0, 4 week and 4 week after treatment'}, {'measure': 'General Impression', 'timeFrame': 'Every week'}, {'measure': 'Laboratory tests', 'timeFrame': 'At 0, 4 week and 4 week after treatment'}, {'measure': 'Adverse Event', 'timeFrame': '4 week treatment period and 4 week after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acotiamide'], 'conditions': ['Functional Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '22157329', 'type': 'DERIVED', 'citation': 'Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent\n* Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)\n* Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent\n\nExclusion Criteria:\n\n* Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent\n* Subjects have heartburn in last 12 weeks before obtaining informed consent\n* Subjects with irritable bowel disease (IBS)\n* Subjects with diabetes mellitus requiring treatment\n* Subjects with serious anxiety disorder\n* Subjects with depression and/or sleep disorder\n* Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)"}, 'identificationModule': {'nctId': 'NCT00761358', 'briefTitle': 'To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeria Pharmaceutical'}, 'officialTitle': 'To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms', 'orgStudyIdInfo': {'id': '99010301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Z-338', 'interventionNames': ['Drug: Z-338']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Z-338', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Z-338']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Michio Hongo, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tohoku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeria Pharmaceutical', 'class': 'INDUSTRY'}}}}