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NCT Number: NCT02737670

Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

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.

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Jospeh University

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulodexide

Drug

25 mg morning and evening for 40 days

Placebo

Drug

1 tablet morning and evening for 40 days

Primary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: At day 0 and at 40 days

    Assessment of changes in THI questionnaire score between Day 40 and 0

Secondary outcomes

  1. Mini Tinnitus Questionnaire (Mini-TQ)

    Time frame: At day 0 and at 40 days

    Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0

  2. Adverse effects

    Time frame: Up to 40 days

    reporting adverse effects by the patient

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Acronym: SECIST

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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