Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-13 @ 1:01 PM
Study NCT ID:
NCT03205228
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2017-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079564', 'term': 'Globus Sensation'}], 'ancestors': [{'id': 'D003291', 'term': 'Conversion Disorder'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'C000851', 'term': 'flupentixol, melitracen drug combination'}], 'ancestors': [{'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'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '28 days', 'description': 'Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study'}], 'secondaryOutcomes': [{'measure': 'Improvement in quality of life', 'timeFrame': '28 days', 'description': 'Changes in the scores assessed by the 36-Item Short Form Health Survey questionnaire from baseline to the end of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Globus']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial study is conducted to compare treatment efficacy between psycho-education, anxiolytics drug and proton pump inhibitors in participants who met the criteria of globus.', 'detailedDescription': 'This is a randomized controlled trial in patients with globus. All participants will be allocated into 3 groups (16 subjects/group) : Proton pump inhibitors (miracid®) , anxiolytics drug (Deanxit®) and psycho-education. The study duration is 4 weeks long.\n\nData regarding clinical severity and quality of life of all participants will be collected at the beginning and at the end of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptoms based on the following criteria: Persistent or intermittent nonpainful sensation of a lump or foreign body in the throat with no structural lesion identified on physical examination, laryngoscopy, or endoscopy.\n\n 1. Occurrence of the sensation between meals.\n 2. Absence of dysphagia or odynophagia\n\nExclusion Criteria:\n\n* Subjects with psychological disease\n* Significant heart disease and/or arrhythmia\n* Proton Pump inhibitors and/or Histamine 2 Receptor Antagonist use within 2 weeks before randomization\n* Mono-amine Oxidase inhibitors or Selective Serotonin Reuptake Inhibitor or Tricyclic antidepressant use within 2 weeks before randomization\n* History of drug allergy that use in research\n* Pregnancy or breast feeding\n* Decline to participate in study'}, 'identificationModule': {'nctId': 'NCT03205228', 'briefTitle': 'Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Treatment Outcomes in Patients With Globus: A Randomized Control Trial of Psychoeducation, Anxiolytics and Proton Pump Inhibitors', 'orgStudyIdInfo': {'id': '004/2560 (EC4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flupentixol + Melitracen & placebo', 'description': 'Deanxit® (Flupentixol + Melitracen) 5 mg/D\\*4 weeks will be given', 'interventionNames': ['Drug: Flupentixol +Melitracen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proton pump inhibitor & placebo', 'description': 'Miracid® (Omeprazole) 20 mg/D\\*4 weeks will be given', 'interventionNames': ['Drug: Omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation&placebo', 'description': 'Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame', 'interventionNames': ['Behavioral: psychoeducation']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Miracid®'], 'description': 'A capsule of Omeprazole 20 mg \\& 1 capsule of placebo will be given in individual subject, once daily for 4 weeks. Both drugs will be presented in the same appearance (white capsule).', 'armGroupLabels': ['Proton pump inhibitor & placebo']}, {'name': 'psychoeducation', 'type': 'BEHAVIORAL', 'otherNames': ['advice for symptoms management'], 'description': 'Psychoeducation will be given by psychologists at the Day 1 and Day 15 of the study period.One white capsule of placebo will be given once daily for 4 weeks of the study period.', 'armGroupLabels': ['Psychoeducation&placebo']}, {'name': 'Flupentixol +Melitracen', 'type': 'DRUG', 'otherNames': ['Deanxit®'], 'description': 'A capsule containing of a tablet of melitracen 10 mg + flupentixol 0.5 mg \\& a capsule of placebo will be given once daily, for 4 weeks. Both would be presented in the same appearance (white capsule)', 'armGroupLabels': ['Flupentixol + Melitracen & placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Division of gastroenterology, Department of Medicine, Siriraj hospital', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'overallOfficials': [{'name': 'Monthira Maneerattanaporn, MD., MS.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}