Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation

NCT ID: NCT05432843

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-12
• Study Completion Date: 2023-01-31

Brief Summary

To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.

Detailed Description

Globus, defined as a feeling of a lump in the throat, unexplained by structural lesions, GERD, or histopathology-based esophageal motility disorders, is a frequently occurring symptom of unknown etiology. Today there is no appropriate treatment for patients with a globus sensation. Pathophysiological mechanisms that have been implicated in the pathogenesis of globus include gastroesophageal reflux disease, oesophageal motor disorders, overactive cricopharyngeal muscle, psychological factors, gastric islet patches in the proximal esophagus and deformations of the cervical spine. However, none of these convincingly explains the clinical picture in globus patients.

Investigators recently observed that a large majority (80%) of patients with persistent globus sensation have a pathological EMG examination of the larynx, indicative of neuropathy in the laryngeal area. The investigators believe that this neuropathy may explain some of the symptoms that are experienced by patients with globus, and may actually contribute to some observations of unclear pathophysiological relevance such as a hyperreactive ciricopharyngeal muscle. Neuropathies may respond to specific therapies, such as the pregabalin.

The aim of the study is to evaluate if treatment with pregabalin (Lyrica®) is effective in these patients. The effect of gabapentin, another anti-epileptic drug with therapeutic efficacy in neuropathy, was evaluated in patients with chronic cough as sign of laryngeal sensory neuropathy. In this study 68% of the patients experienced improvement, with an even higher efficacy in the group of patients with a pathological EMG (80%).

In order to better understand the underlying pathophysiology, and how this responds to therapy, the investigators will also evaluate upper esophageal sphincter high resolution manometric properties during the study. An elevated resting pressure in the upper sphincter was already reported in previous studie, but not confirmed in a more recent study, which did report a hyperreactive UES, mainly characterized by a hyperdynamic respiratory pressure change.

Esophageal inlet patches have also been implicated in the pathogenesis of globus, although the exact mechanism remains unclear. In the present study, all patients will undergo a strict evaluation of the upper part of the esophagus during endoscopy, to document presence or absence of inlet patches.

Conditions

Globus Sensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin

Treatment with pregabalin in the treatment of globus sensation

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Patients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg

Placebo

Treatment with placebo in the treatment of globus sensation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients receive a treatment with placebo for 8 weeks

Interventions

Pregabalin

Patients receive for one week Pregabalin 75 mg and 7 weeks Pregabalin 150 mg

Intervention Type: DRUG

Placebo

Patients receive a treatment with placebo for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Lyrica

Eligibility Criteria

Inclusion Criteria

• Age 18-80 years
• Globus symptoms for more than three months
• First symptoms > 6 months ago
• Signed informed consent

Exclusion Criteria

• Gabapentin/pregabalin treatment
• Unstable neuroleptic or antidepressive treatment (stable dose during min 8 weeks)
• Symptom relief under PPI treatment (min 8 weeks full dose)
• Patients with persisting esophagitis of Los Angeles grade B or higher under PPI on upper GI endoscopy
• Primary esophageal motility disorder (achalasia, scleroderma, dermatomyositis, …)
• Eosinophilic esophagitis
• Candida esophagitis
• Mechanical explanation of symptoms (e.g. stricture in the pharyngo-esophageal region)
• Pregnancy or plans for pregnancy in the next 12 months (in females)
• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Dr Jan Tack

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Leuven

Leuven, België, Belgium

Site Status: RECRUITING

Annelies Geeraerts

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Annelies Geeraerts, MsC

Role: CONTACT

Annelies.Geeraerts@kuleuven.be

016343385

Facility Contacts

Annelies Geeraerts

Role: primary

annelies.geeraerts@kuleuven.be

+32497671229

Annelies Geeraerts, PhD student

Role: primary

annelies.geeraerts@kuleuven.be

01643385

Other Identifiers

S52107

Identifier Type: -

Identifier Source: org_study_id