Effect of Baclofen on PPI-non-responded globus pharyngeus correlated with high-resolution manometry: a randomized double-blind placebo-controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20181212001

Enrollment

Registered

2018-12-12

Start date

2018-12-26

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PPI&#45

Interventions

Its chemical name is 4&#45

amino&#45

3&#45

(4&#45

chlorophenyl) butanoic acid. It acts as gamma&#45

aminobutyric acid type B (GABA&#45

B) receptor agonist. Baclofen tablet is composed of white&#44

odorless crystalline powder. It is slightly soluble in water. Each tablet&#44

for oral administration&#44

contains 10 mg baclofen.,Paceblo tablet will be produced by Research administration and Service office&#44

Faculty of Pharmaceutical Sciences&#44

Prince of Songkla University. It will be presented in the same appearance (white round tablet) as Baclofen tablet. It contains safe ingredients with no effect on therapeutic value.

Active Comparator Drug,Placebo Comparator Drug

Baclofen,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Age 18-50 years - Persistent globus symptoms despite of 2 week double doses or high dose PPI therapy with good compliance with symptom improvement less than fifty percent from baseline 23,24 - No structural lesion identified on neck & nasolaryngeal examination - Absence of alarming symptoms ( for example; dysphagia, odynophagia, sore throat, significant weight loss ) - GERD-Q score25,26 < 8

Exclusion criteria

Exclusion criteria: - Known allergy to Baclofen - Epilepsy or history of seizures - Renal impairement: estimated glomerular filtration rate <60 ml/min/1.73m2 - Centrally modulating agents or prokinetic drugs use within 2 weeks before randomization - Pregnancy or lactation - Major esophageal motor disorders (achalasia, EGJ outflow obstruction, diffuse esophageal spasm, jackhammer esophagus, absent peristalsis)

Design outcomes

Primary

Measure	Time frame
Proportion of patients with >50% globus symptom improvement after 4 weeks of baclofen at baseline and 4 weeks after Baclofen or Placebo GETS score, Esophageal high-resolution manometry	—

Secondary

Measure	Time frame
effect of Baclofen to UES & esophageal body motility at baseline and 4 weeks esophageal high-resolution manometry	—

Countries

Thailand

Contacts

Public ContactSawangpong Jandee

Faculty of Medicine, Prince of Songkla University

tekikung@gmail.com0896461605

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Effect of Baclofen on PPI&#45;non&#45;responded globus pharyngeus correlated with high&#45;resolution manometry: a randomized double&#45;blind placebo&#45;controlled trial.