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

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Globus

Treatments: Drug: Flupentixol +Melitracen; Drug: Omeprazole; Behavioral: psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03205228

004/2560 (EC4)

Details and patient eligibility

About

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.

Full description

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.

Data regarding clinical severity and quality of life of all participants will be collected at the beginning and at the end of treatment.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

  1. Occurrence of the sensation between meals.
  2. Absence of dysphagia or odynophagia

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups

Flupentixol + Melitracen & placebo

Experimental group

Description:

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

Treatment:

Drug: Flupentixol +Melitracen

Proton pump inhibitor & placebo

Active Comparator group

Description:

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

Treatment:

Drug: Omeprazole

Psychoeducation&placebo

Active Comparator group

Description:

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

Treatment:

Behavioral: psychoeducation