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

Phase 3

Completed

• Conditions: Globus
• Interventions: Drug: Flupentixol +Melitracen; Behavioral: psychoeducation; Drug: Omeprazole

• Registration Number: NCT03205228
• Lead Sponsor: Mahidol University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-07-07
• Primary Completion: 2018-06-26
• Study Completion: 2018-07-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flupentixol + Melitracen & placebo	Flupentixol +Melitracen	Deanxit® (Flupentixol + Melitracen) 5 mg/D\*4 weeks will be given
Psychoeducation&placebo	psychoeducation	Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame
Proton pump inhibitor & placebo	Omeprazole	Miracid® (Omeprazole) 20 mg/D\*4 weeks will be given

Primary Outcome Measures

Name	Time	Method
Clinical improvement	28 days	Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life	28 days	Changes in the scores assessed by the 36-Item Short Form Health Survey questionnaire from baseline to the end of the study.

Trial Locations

Locations (1)

Division of gastroenterology, Department of Medicine, Siriraj hospital; 🇹🇭 Bangkok Noi, Bangkok,, Thailand