Clinical study tha evaluates the efficacy of a PUFA based drug on acustic disturbances represented by the perception of annoying noises (whistles, hums).
Phase 1
- Conditions
- Primary tinnitusMedDRA version: 20.0Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disordersTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2015-003514-24-IT
- Lead Sponsor
- IBSA FARMACEUTICI ITALIA SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients of both gender with age 18-80 years.
Diagnosis of primary tinnitus (level 3-5, according to THI).
Written 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
Controindications or hypersensitivity to Olevia or to one of its components.
Secondary tinnitus.
Haepatic impairment.
Moderate to severe renal impairment.
Ischemic heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and safety of Olevia (omega-3 polyunsatured acid based drug) in both genders patients affectted by primary tinnitus.;Secondary Objective: Evaluation of level of compliance to the treatment.<br>Evaluation of the level of reduction of hyperacusia.<br>Evaluation of rate and entity of adverse events.;Primary end point(s): Evaluation of the level of reduction of the primary tinnitus, through THI scale, in both groups.;Timepoint(s) of evaluation of this end point: 2 months and 3 months after baseline visit.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluation of level of compliance to treatment throu, in both groups.gh questionnary, in both groups.<br>Evaluation of level of reduction of hyperacusia through questionnary.<br>Evaluation of rate and entity of adverse evnts in both groups.; Evaluation of the grade of compliance to treatment by questionnaire in both groups*.<br>Evaluation of the grade of reduction of hyperacusis by questionnaire (Khalfa), in both groups**.<br>Evaluation of the rate and extent of adverse events in both groups***.;Timepoint(s) of evaluation of this end point: 2 months and 3 months after baseline visit.; *2 month and 3 month after basaline visit<br>**month and 3 month after basaline visit<br>***month and 3 month after basaline visit