Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors
NCT ID: NCT03205228
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2017-07-07
2018-07-28
Brief Summary
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Detailed Description
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Data regarding clinical severity and quality of life of all participants will be collected at the beginning and at the end of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Flupentixol + Melitracen & placebo
Deanxit® (Flupentixol + Melitracen) 5 mg/D\*4 weeks will be given
Flupentixol +Melitracen
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)
Proton pump inhibitor & placebo
Miracid® (Omeprazole) 20 mg/D\*4 weeks will be given
Omeprazole
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).
Psychoeducation&placebo
Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame
psychoeducation
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.
Interventions
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Omeprazole
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).
psychoeducation
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.
Flupentixol +Melitracen
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
1. Occurrence of the sensation between meals.
2. Absence of dysphagia or odynophagia
Exclusion Criteria
* Significant heart disease and/or arrhythmia
* Proton Pump inhibitors and/or Histamine 2 Receptor Antagonist use within 2 weeks before randomization
* Mono-amine Oxidase inhibitors or Selective Serotonin Reuptake Inhibitor or Tricyclic antidepressant use within 2 weeks before randomization
* History of drug allergy that use in research
* Pregnancy or breast feeding
* Decline to participate in study
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Monthira Maneerattanaporn, MD., MS.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Division of gastroenterology, Department of Medicine, Siriraj hospital
Bangkok Noi, Bangkok, Thailand
Countries
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Other Identifiers
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004/2560 (EC4)
Identifier Type: -
Identifier Source: org_study_id
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