GlobusPhase 3NCT03205228
Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors
A Phase 3 study testing Omeprazole, psychoeducation and Flupentixol +Melitracen in people with Globus, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Globus
- What is being tested?
- Omeprazole, psychoeducation and Flupentixol +Melitracen
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 7 Jul 2017to 28 Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of gastroenterology, Department of Medicine, Siriraj hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Conditions
- Globus
- Being tested
- Omeprazole, psychoeducation, Flupentixol +Melitracen
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Miracid®
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).
psychoeducationBehavioural
Also called advice for symptoms management
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.
Flupentixol +MelitracenDrug
Also called Deanxit®
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)
| Study group | Role | What they receive |
|---|---|---|
| Flupentixol + Melitracen & placebo | Experimental | Deanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given Receives: Drug: Flupentixol +Melitracen |
| Proton pump inhibitor & placebo | Active comparator | Miracid® (Omeprazole) 20 mg/D*4 weeks will be given Receives: Drug: Omeprazole |
| Psychoeducation&placebo | Active comparator | Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame Receives: Behavioral: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study
Measured: 28 days
Secondary outcomes (1)
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start7 Jul 2017
- Primary completion26 Jun 2018
- Study completion28 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlobusStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monthira Maneerattanaporn, MD., MS., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205228
- Sponsor's protocol ID
- 004/2560 (EC4)
- Status last verified
- Aug 2018
- First submitted
- 22 Jun 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes in Patients With Globus: A Randomized Control Trial of Psychoeducation, Anxiolytics and Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT03205228
- Acronym / sponsor ID
- 004/2560 (EC4)
- Conditions
- Globus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 28 Jul 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flupentixol + Melitracen & placebo | Experimental | Drug: Flupentixol +MelitracenDeanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given |
| Proton pump inhibitor & placebo | Active comparator | Drug: OmeprazoleMiracid® (Omeprazole) 20 mg/D*4 weeks will be given |
| Psychoeducation&placebo | Active comparator | Behavioral: psychoeducationPsychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Miracid®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). | Drug | Proton pump inhibitor & placebo |
| psychoeducationAlso: advice for symptoms managementPsychoeducation 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. | Behavioural | Psychoeducation&placebo |
| Flupentixol +MelitracenAlso: Deanxit®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) | Drug | Flupentixol + Melitracen & placebo |
Primary outcome
Clinical improvement
Time frame: 28 days
Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study
1 secondary outcome
Improvement in quality of life
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monthira Maneerattanaporn, MD., MS. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole, psychoeducation and Flupentixol +Melitracen in people with Globus, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.