Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors

NCT03205228 | Completed Phase 3

• 1 other identifier: 004/2560 (EC4)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Globus

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study

  28 days

Secondary Outcomes (1)

• Improvement in quality of life

  28 days

Study Arms (3)

Flupentixol + Melitracen & placebo

EXPERIMENTAL

Deanxit® (Flupentixol + Melitracen) 5 mg/D\*4 weeks will be given

Drug: Flupentixol +Melitracen

Proton pump inhibitor & placebo

ACTIVE COMPARATOR

Miracid® (Omeprazole) 20 mg/D\*4 weeks will be given

Drug: Omeprazole

Psychoeducation&placebo

ACTIVE COMPARATOR

Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame

Behavioral: psychoeducation

Interventions

Omeprazole DRUG

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).

Also known as: Miracid®

Proton pump inhibitor & placebo

psychoeducation BEHAVIORAL

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.

Also known as: advice for symptoms management

Psychoeducation&placebo

Flupentixol +Melitracen DRUG

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)

Also known as: Deanxit®

Flupentixol + Melitracen & placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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.
• Occurrence of the sensation between meals.
• Absence of dysphagia or odynophagia

You may not qualify if:

• Subjects with psychological disease
• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Division of gastroenterology, Department of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Globus Sensation

Interventions

Omeprazole; Counseling; Palliative Care; flupentixol, melitracen drug combination

Condition Hierarchy (Ancestors)

Conversion Disorder; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Patient Care; Therapeutics

Study Officials

• Monthira Maneerattanaporn, MD., MS.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: July 7, 2017
• Primary Completion: June 26, 2018
• Study Completion: July 28, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)