Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with inner ear vertigo.

Phase 1

• Conditions: Vertigo of peripheral origin; MedDRA version: 16.1Level: LLTClassification code 10031615Term: Other and unspecified peripheral vertigoSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 16.1Level: LLTClassification code 10058708Term: Rotatory vertigoSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 16.1Level: PTClassification code 10047344Term: Vertigo labyrinthineSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 16.1Level: LLTClassification code 10034641Term: Peripheral vertigo, unspecifiedSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 16.1Level: LLTClassification code 10032379Term: Other peripheral vertigoSystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2011-004025-27-BG
• Lead Sponsor: HENNIG ARZNEIMITTEL GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

caucasian
written Informed Consent of the patient
age = 18
patient has vertigo sensations of peripheral-vestibular origin, e.g. Menière-like symptoms
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 178
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified