E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vertigo of peripheral origin |
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E.1.1.1 | Medical condition in easily understood language |
Vertigo originated in the inner ear |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031615 |
E.1.2 | Term | Other and unspecified peripheral vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058708 |
E.1.2 | Term | Rotatory vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047344 |
E.1.2 | Term | Vertigo labyrinthine |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034641 |
E.1.2 | Term | Peripheral vertigo, unspecified |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10032379 |
E.1.2 | Term | Other peripheral vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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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 |
The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin. |
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E.2.2 | Secondary objectives of the trial |
Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale) |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Socio-Economic Appendix (Piggyback) on costs and charges emerged during treatment of patients with peripheral vertigo. The purpose of this piggyback is to document resource utilization and to perform a cost-utility analysis and a cost-minimization analysis. |
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E.3 | Principal inclusion criteria |
caucasian written Informed Consent of the patient age ≥ 18 patient has vertigo sensations of peripheral-vestibular origin, e.g. Menière-like symptoms |
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E.4 | Principal exclusion criteria |
simultaneous participation in another clinical study patient did not voluntarily sign the informed consent form intake of antivertiginous or cerebrovascularly active medication that cannot be discontinued known allergic reactions to one of the active substances of the study medication (cinnarizine, dimenhydrinate and/or betahistine dihydrochloride) known hypersensitivity to various medicaments suspicion of alcohol and/or drug abuse psychiatric diseases, insanity epilepsy or convulsive fits acute infections severe chronic or terminal diseases (cancer, tuberculosis) any disease that could affect absorption, metabolism or elimination of the study medication acute poisoning suspected pregnancy / nursing period / women of child-bearing potential, if no safe contraception can be guaranteed during the study chronic inflammatory middle ear diseases Parkinson’s disease suspected compressive intracranial processes suspected narrow-angle glaucoma suspected prostate adenoma with formation of residual urine in the bladder severe renal insufficiency chronic liver disease treatment with aminoglycosidic antibiotics treatment with monoaminooxidase inhibitors, tricyclic antidepressants, para-sympatholytics, glucocorticoids and/or heparin that cannot be discontinued phaeochromocytoma peptic ulcer |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change in the Mean Vertigo Score (MVS) from Baseline to Week 4, defined as the mean of the intensities of six unprovoked vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation and blackout) and of vertigo in consequence of six triggering factors (change of position, bowing, getting up, driving by car/train, head movements, and eye movement), as subjectively judged by the patient. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline and after 4 weeks of treatment |
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E.5.2 | Secondary end point(s) |
Changes in Mean Vertigo Score after 1 week of therapy Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment Evaluation of global efficacy by both the investigator and the patient (5-point scale) Evaluation of the patient’s ability to cope with daily activities (3-point scale) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, after 1 week and after 4 weeks of treatment |
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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 | No |
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Bulgaria |
Russian Federation |
Czech Republic |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |