Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Phase 2

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Drug: Placebo; Drug: Sulodexide

• Registration Number: NCT02737670
• Lead Sponsor: St Joseph University, Beirut, Lebanon

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-04-03
• Study First Submitted QC: 2016-04-10
• Study First Posted: 2016-04-14
• Primary Completion: 2017-03
• Status Verified: 2017-04
• Study Completion: 2017-08
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 tablet twice per day for 40 days
Sulodexide	Sulodexide	Sulodexide 25 mg twice per day for 40 days

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory (THI)	At day 0 and at 40 days	Assessment of changes in THI questionnaire score between Day 40 and 0

Secondary Outcome Measures

Name	Time	Method
Mini Tinnitus Questionnaire (Mini-TQ)	At day 0 and at 40 days	Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Adverse effects	Up to 40 days	reporting adverse effects by the patient

Trial Locations

Locations (1)

St Jospeh University; 🇱🇧 Beirut, Lebanon