A Randomized Controlled Trial Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Pregabalin

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,