Clinical study tha evaluates the efficacy of a PUFA based drug on acustic disturbances represented by the perception of annoying noises (whistles, hums).

Phase III study, double blind, placebo controlled, to evaluate the efficacy and the safety of an omega-3 based drug, in patients with primary tinnitus. - Efficacy of omega-3 on primary tinnitus

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003514-24-IT

Enrollment

100

Registered

2021-05-24

Start date

2016-07-15

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary tinnitus MedDRA version: 20.0 Level: PT Classification code 10043882 Term: Tinnitus System Organ Class: 10013993 - Ear and labyrinth disorders

Interventions

Trade Name: OMEGAIBSA2 - 1000 MG CAPSULA MOLLE 2X10 CAPSULE Product Name: OLEVIA 1000 mg - Il nome corrispondente in banca dati OsSC è OMEGAIBSA2 Product Code: [042639029] Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Evaluation of the level of reduction of hyperacusia. 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.	—

Measure

Time frame

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. Evaluation of the level of reduction of hyperacusia. 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

Measure	Time frame
Secondary end point(s): Evaluation of level of compliance to treatment throu, in both groups.gh questionnary, in both groups. Evaluation of level of reduction of hyperacusia through questionnary. Evaluation of rate and entity of adverse evnts in both groups.; Evaluation of the grade of compliance to treatment by questionnaire in both groups. Evaluation of the grade of reduction of hyperacusis by questionnaire (Khalfa), in both groups. 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 month and 3 month after basaline visit *month and 3 month after basaline visit	—

Measure

Time frame

Secondary end point(s): Evaluation of level of compliance to treatment throu, in both groups.gh questionnary, in both groups. Evaluation of level of reduction of hyperacusia through questionnary. Evaluation of rate and entity of adverse evnts in both groups.; Evaluation of the grade of compliance to treatment by questionnaire in both groups*. Evaluation of the grade of reduction of hyperacusis by questionnaire (Khalfa), in both groups**. 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 **month and 3 month after basaline visit ***month and 3 month after basaline visit

—

Countries

Italy

Contacts

Public ContactCRO

Informa PRO S.r.l.

segreteria@informa.pro065758926

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026