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

Treatment Outcomes in Patients With Globus: A Randomized Control Trial of Psychoeducation, Anxiolytics and Proton Pump Inhibitors

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.

Study Overview

• Status: Completed
• Conditions: Globus
• Intervention / Treatment: Drug: Flupentixol +Melitracen; Drug: Omeprazole; Behavioral: psychoeducation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok,
    • Bangkok Noi, Bangkok,, Thailand, 10700
      • Division of gastroenterology, Department of Medicine, Siriraj hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flupentixol + Melitracen & placebo; Deanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given	Drug: 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 Names: Deanxit®
Active Comparator: Proton pump inhibitor & placebo; Miracid® (Omeprazole) 20 mg/D*4 weeks will be given	Drug: 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).; Other Names: Miracid®
Active Comparator: Psychoeducation&placebo; Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame	Behavioral: 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.; Other Names: advice for symptoms management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Monthira Maneerattanaporn, MD., MS., Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): June 26, 2018
• Study Completion (Actual): July 28, 2018

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Conversion Disorder; Somatoform Disorders; Globus Sensation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole; Flupenthixol; Flupenthixol decanoate
• Other Study ID Numbers: 004/2560 (EC4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No