A randomized controlled trial comparing pregabalin and placebo in patients with persistent globus sensation

INTERVENTION: 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: 150‐300 Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Globus symptoms ; MedDRA version: 12.1 Level: LLT Classification code 10051180 Term: Globus feeling in pharynx PRIMARY OUTCOME: Main Objective: To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo; ; ; 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; Secondary Objective: /; ; 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