Globus symptoms MedDRA version: 12.1 Level: LLT Classification code 10051180 Term: Globus feeling in pharynx
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
CAS Number: 148553-50-8
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-80 years Globus symptoms for more than three months First symptoms > 6 months ago Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Neuroleptic, antidepressive or gabapentin/pregabalin treatment 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, …) 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo ;Secondary Objective: / ;Primary end point(s): Hypothesis 1 After 8 weeks of treatment, the proportion of patients who are in clinical remission will be statistically significantly higher in the pregabalin group than those allocated to placebo treatment. Hypothesis 2 The reduction of GETS will be statistically significantly higher in the pregabalin group than in those allocated to placebo treatment. Hypothesis 3 The overall treatment evaluation by the patient will be significantly more favorable in the pregabalin group than in those allocated to placebo treatment. Hypothesis 4 After 8 weeks of treatment, patients with a pathological EMG registration have clinically higher reduction of the GETS than those with a normal EMG registration. Hypothesis 5 After 8 weeks of treatment the reduction of the hypercontractility of the UES wil be higher in the pregabalin group | — |
Countries
Belgium
Outcome results
None listed