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Betahistine trial in adult patients with Meniere's disease
THE OBJECTIVE OF THE STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF THE DRUG BETAHISTINE PR 48 MG (EXTENDED RELEASE AND ONCE DAILY).
Technical Summary
- MULTICENTER, THREE-ARM, DOUBLE-BLIND, DOUBLE-DUMMY, DOUBLE-DUMMY, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF THE EXTENDED-RELEASE FORMULATION OF BETAHISTIN PR 48 MG ONCE DAILY COMPARED TO THE CONVENTIONAL RELEASE FORMULATION OF BETAHISTIN IR 24 MG, TWICE DAILY IN THE TREATMENT OF ADULT PATIENTS WITH MENIERE'S DISEASE.
- Code EudraCT: 2020-005246-42
- Protocol number: 0796-19
- Promoter: Intas Pharmaceuticals Limited
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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