NCT02737670

Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: St Joseph University, Beirut, Lebanon · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus, Subjective

Interventions

Type	Name	Description
DRUG	Sulodexide	25 mg morning and evening for 40 days
DRUG	Placebo	1 tablet morning and evening for 40 days

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-03-01
• Completion: 2017-08-01
• First posted: 2016-04-14
• Last updated: 2017-09-14

Locations

1 site across 1 country: Lebanon