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NCT Number: NCT03205228

Treatment in Patients With Globus: Psychoeducation, Anxiolytics or 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.

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Key information

Conditions

Globus Conversion Disorder Globus Sensation Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of gastroenterology, Department of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Occurrence of the sensation between meals.
  • 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

Treatment and study plan

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).

Other names: Miracid®

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.

Other names: advice for symptoms management

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)

Other names: Deanxit®

Primary outcomes

  1. Clinical improvement

    Time frame: 28 days

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

Secondary outcomes

  1. Improvement in quality of life

    Time frame: 28 days

    Changes in the scores assessed by the 36-Item Short Form Health Survey questionnaire from baseline to the end of the study.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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