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

Phase 3

• Conditions: PPI- non- responded globus pharyngeus; globus pharyngeus, high- resolution manometry, Baclofen

• Registration Number: TCTR20181212001
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study Completion: 2019-11-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 62

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

-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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
effect of Baclofen to UES & esophageal body motility at baseline and 4 weeks esophageal high-resolution manometry