Status:
UNKNOWN
Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Globus Sensation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 etiol...
Eligibility Criteria
Inclusion
- Age 18-80 years
- Globus symptoms for more than three months
- First symptoms \> 6 months ago
- Signed informed consent
Exclusion
- 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,
Key Trial Info
Start Date :
March 12 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05432843
Start Date
March 12 2010
End Date
January 1 2023
Last Update
July 6 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Leuven
Leuven, België, Belgium, 3000
2
Annelies Geeraerts
Leuven, Belgium, 3000