Clinical Trials Register

Summary
EudraCT Number:	2015-003514-24
Sponsor's Protocol Code Number:	OLEV01/2015
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-24
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-003514-24

A.3

Full title of the trial

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.

Studio di fase III, in doppio cieco, controllato con placebo, per valutare l'efficacia e la sicurezza di un medicinale a base di omega-3 in pazienti affetti da acufeni primari.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studio clinico che valuta l'efficacia di un farmaco a base di acidi grassi polinsaturi su disturbi uditivi rappresentati dalla percezione di rumori fastidiosi (sibili, ronzii).

A.3.2

Name or abbreviated title of the trial where available

Efficacy of omega-3 on primary tinnitus

Efficacia di omega-3 su acufeni primari

A.4.1

Sponsor's protocol code number

OLEV01/2015

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	IBSA FARMACEUTICI ITALIA SRL
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ibsa Farmaceutici Italia Srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Informa PRO S.r.l.
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Rava, 43
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00149
B.5.3.4	Country	Italy
B.5.4	Telephone number	065758926
B.5.5	Fax number	0662207168
B.5.6	E-mail	segreteria@informa.pro

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMEGAIBSA2 - 1000 MG CAPSULA MOLLE 2X10 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OLEVIA 1000 mg - Il nome corrispondente in banca dati OsSC è OMEGAIBSA2
D.3.2	Product code	[042639029]
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gli acidi grassi polinsaturi della serie omega-3, Acido eicosapentaenoico (EPA) e acido docosaesaenoico (DHA)
D.3.9.2	Current sponsor code	20249
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary tinnitus

Acufeni di natura primaria

E.1.1.1

Medical condition in easily understood language

Perception of .annoying.noises (whistles, hums, etc) that impair the quality of life of the patients which are affected by this clinical condition.

Percezione di rumori fastidiosi (sibili, ronzii,etc) che alterano la qualità di vita dei pazienti che sono affetti da questa condizione clinica.

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10043882
E.1.2	Term	Tinnitus
E.1.2	System Organ Class	10013993 - Ear and labyrinth disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the efficacy and safety of Olevia (omega-3 polyunsatured acid based drug) in both genders patients affectted by primary tinnitus.

Valutazione dell'efficacia e della sicurezza di Olevia (medicinale a base di acidi polinsaturi omega-3) in una popolazione di pazienti ambosessi affetti da acufeni primari (grado 3-5, secondo THI).

E.2.2

Secondary objectives of the trial

Evaluation of level of compliance to the treatment.
Evaluation of the level of reduction of hyperacusia.
Evaluation of rate and entity of adverse events.

Valutazione del grado di compliance al trattamento.
Valutazione del grado di riduzione dell'iperacusia.
Valutazione del tasso e dell'entità degli eventi avversi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients of both gender with age 18-80 years.
Diagnosis of primary tinnitus (level 3-5, according to THI).
Written informed consent.

Pazienti di sesso maschile/femminile con età compresa tra 18-80 anni.
Diagnosi di acufeni primari (grado 3-5, secondo THI).
Consenso informato scritto.

E.4

Principal 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

Controindicazioni o ipersensibilità a Olevia o ad uno dei suoi componenti.
Acufeni di natura secondaria.
Insufficienza epatica.
Insufficienza renale di grado moderato-severo.
Cardiopatia ischemica.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of the level of reduction of the primary tinnitus, through THI scale, in both groups.

Valutazione del grado di riduzione della percezione degli acufeni primari, mediante scala THI, in entrambi i gruppi.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 months and 3 months after baseline visit.

2 mesi e 3 mesi dopo la visita basale.

E.5.2

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***.

Valutazione del grado di compliance al trattamento mediante questionario, in entrambi i gruppi.
Valutazione del grado di riduzione della iperacusia, mediante questionario (Khalfa), in entrambi i gruppi.
Valutazione del tasso e dell'indice di eventi avversi, in entrambi i gruppi.; Valutazione del grado di compliance al trattamento mediante questionario in entrambi i gruppi.
Valutazione del grado di riduzione della iperacusia mediante questionario (Khalfa), in entrambi i gruppi.
Valutazione del tasso e dell'entità degli eventi avversi, in entrambi i gruppi.

E.5.2.1

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

2 mesi e 3 mesi dopo la visita basale.; * 2 mesi e 3 mesi dopo la visita basale
** 2 mesi e 3 mesi dopo la visita basale
*** 2 mesi e 3 mesi dopo la visita basale

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Follow up to evaluate the effiicacy of the the study therapy and, if applicable, administration of alternative therapies

Follow up per valutazione della efficacia della terapia in studio e, se applicabile, somministrazione di terapie alternative.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-03-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-07-15

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials