E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051180 |
E.1.2 | Term | Globus feeling in pharynx |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-80 years Globus symptoms for more than three months First symptoms > 6 months ago Signed informed consent
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E.4 | Principal 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,
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
a 8 week double blind randomised phase followed by a 8 week open label phase |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |