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

Globus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205228
• Other study ID #: 004/2560 (EC4)
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2017
• Est. completion date: July 28, 2018

Study information

• Verified date: August 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 28, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Globus

Intervention

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).

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.

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)

Locations

Country	Name	City	State
Thailand	Division of gastroenterology, Department of Medicine, Siriraj hospital	Bangkok Noi	Bangkok,

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study	28 days
Secondary	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