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

Primary Purpose

Globus

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Omeprazole

psychoeducation

Flupentixol +Melitracen

About this trial

This is an interventional treatment trial for Globus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Division of gastroenterology, Department of Medicine, Siriraj hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Flupentixol + Melitracen & placebo

Proton pump inhibitor & placebo

Psychoeducation&placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Clinical improvement

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03205228

First Posted

June 22, 2017

Last Updated

August 21, 2018

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03205228

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 7, 2017 (Actual)

Primary Completion Date

June 26, 2018 (Actual)

Study Completion Date

July 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Globus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flupentixol + Melitracen & placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Proton pump inhibitor & placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Psychoeducation&placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Other Intervention Name(s)

Miracid®

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

psychoeducation

Other Intervention Name(s)

advice for symptoms management

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Flupentixol +Melitracen

Other Intervention Name(s)

Deanxit®

Intervention Description

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)

Primary Outcome Measure Information:

Title

Clinical improvement

Description

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Improvement in quality of life

Description

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monthira Maneerattanaporn, MD., MS.

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of gastroenterology, Department of Medicine, Siriraj hospital

City

Bangkok Noi

State/Province

Bangkok,

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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