Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

NCT ID: NCT02737670

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-08-31

Brief Summary

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The objective of this prospective randomized and double blind controlled study is to evaluate the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic subjective tinnitus.

Detailed Description

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Patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited from our Ear, Nose and Throat (ENT) clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1- Sulodexide 25 mg for 40 days 2- Placebo for 40 days. Clinical evaluation of the patient is performed; tinnitus is assessed according to Tinnitus Handicap Inventory score, Mini Tinnitus Questionnaire score. Adverse effects are also noted. Patients are followed at 40 days post-treatment and outcome measures are assessed.

Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sulodexide

Sulodexide 25 mg twice per day for 40 days

Group Type ACTIVE_COMPARATOR

Sulodexide

Intervention Type DRUG

25 mg morning and evening for 40 days

Placebo

1 tablet twice per day for 40 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet morning and evening for 40 days

Interventions

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Sulodexide

25 mg morning and evening for 40 days

Intervention Type DRUG

Placebo

1 tablet morning and evening for 40 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Tinnitus for minimum of 1 year
* Absence of psychiatric or neurological diseases
* Absence of any disease that explains tinnitus
* Noise-induced hearing loss
* Cochlear and retro-cochlear damage

Exclusion Criteria

* Conductive hearing loss
* Mixed hearing loss
* Meniere's disease
* Systemic vascular disease
* Diabetic disease
* Vestibular schwannoma
* Cerebello-pontine angle tumors
* Pulsatile tinnitus
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role lead

Responsible Party

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Dr Joseph Maarrawi

Head of the Laboratory of Neurosciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elias Eter, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine - St Joseph University

Locations

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St Jospeh University

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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SULO-TINNITUS

Identifier Type: -

Identifier Source: org_study_id

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